EUROPEAN PHARMACOPOEIA 10.0 4. Reagents 4. Reagents 481 413. Buller solutions 602 Reagents standard solutions, bulfer solutions 48142. Volumetric analysis 609 1. Reagents 481 421, Primary standard: for volumetric solutions, 609 441.2 Standard solutions for limit tert 588 422. Volimetic solutions 609 ws ‘General Notices (2) apply to all monographs and other texts 4, ReagentsUROPEAN PHARMACK OPOEIA 100 oy ‘See the information section on general monograph (over pages}EUROPEAN PHARMACOPOEIA 10.0 4.11, Reagents 04/2013:40000 4, REAGENTS Additional information for reagents that can only be fully ‘dentfed by a trademark or whose availability s limited may be found in the Knowledge database othe EDQM website. This information és giver ely to make i easier to obtain such reagents and this does not suggest in any way tha the Imentioned suppliers are especially recommended or certified by the European Pharmacopoeia Commission or the Council of Europe. Tris therefore acceptable to use reagents from another {source provided that they comply with the standards ofthe Pharmacopoca. BS 4.1. REAGENTS, STANDARD SOLUTIONS, BUFFER SOLUTIONS Where the name of a substance or a golution is followed by the letir R (the whole in stalies), this indicales a reagent included sn the following list. The specifications given for reagents do not necessarily guarantee their quality for use in medicines, Within the description ofeach reagent there is 7-digit reference code in sales (for example, 1002501). This number ‘which will remain unchanged for & given reagent during subsequent revisions of thelist, is used fo identification purposes bythe Secretariat and users of the Pharmacopocia fay’also find i useful, for example in the management of reagent stocks. The description may also include a CAS ber (Chemical Abstract Service Registry Number) ognisable by its typical format, for example 8002-98-1. Some ofthe reagents included i th lis ate toxic and are to be handled in conformity with good quaity contra laboratory Reagents in aqueous solution are prepared using water R For ligaid chromatography, water for chromatography Rie zed for the preparation of mobile phases when water, of an queos solution, is one of the components, Where a reagent ‘lation i described using an expression such as hydrochloric acid (10 g/l. HCH): the solution is prepared by an appropriate “lution wth waler R of a more concentrated reagent solstion specified inthis chapter: Reagent solutions used ithe limit tert for barium, calcium and sulfates are prepared using distied water R. Where the name ofthe solvent isnot stated, an aqueous solution is intended. ‘The reagents and reagent solutions are to be stored in wel closed containers. The labeling should comply with the {elevant national legislation and international agreements. a 4.1.1, REAGENTS Acacia, 1000100, See Acacia (0307). o7/2018:40100 01/2020:40101 ‘Acacia solution, 1090101 Dissolve 100 of acacia Rin 1000 ml. of water R. Stir with A mechanial stirrer for 2h, Centrifuge at about 2000 for 30'min to obtain a clear solution. Storage: in polyethylene containers of abot 250 ml. capacity ata temperature of 0°C to = 20° Acebutolol hydrochloride, 1148500, (34381-68-5 See Acebutoll hydrochloride (0872) Acetal. CH,,0,. (Mf, 1182), 1112300. (105-57. ‘Acetaldchyde diethyl acetal. 11-Disthoxyethane, Clear, colourless, volatile Liquid, miscible with wate «ethanol (96 percent), 3}: abou 0.824 13 about 1.382 bp: about 108 °C Acetaldehyde. Fthanal, (Clear, colourless flammable liguid, miscible with water and with ethanol (95 percent). show 0.788 4, Reagent 10 (M, 44.1). 1000200. (75-07-0) ng: about 1.332, bp about 21°C. ‘Acctaldchyde ammonia trimer trihydrate CuH,.N, 310. (Mf, 183.3). 1133500. [58082-80-5] 2.46: Trimelbylbexa Content: minimum 95.0 per cent Golourless or white or pale yellow crystals or powder mp: 95°C t0 97 °C. Aztay, Dissolve 0.900 g in water Rand dilute to 50.0 ml. ‘with the same solvent. Titrate with 1 M Iydrochioric acid Aetermining the end-point potentiometically (2.220) inl. of 1 M hydrochloric acid is equivalent lo 61,08 mg of CH.N,3H,0. ‘Acetic acid, anhydrous. C.H,0, (M, 60.1). 1000300, {ot-19-7] Content: minimum 99.6 percent m/m of C,11,0, Colourless liquid ox white or almost white, shining, fern like czystals, mize with o very soluble in water, in ethanol (95 per cent. in glycerl (85 per cent), and in most fatty and cseential ol 38: 1.052 wo 1.058, bp: 117 °C @ 119°C. ‘A 100 gil solution is strongly aed (22.4) ‘5 g/l-soluion neutralised with dilute animonia R2 gives reaction (b) of acetates (23. Freezing point (2.2.18) Water (2.5.12): maximum 04 per cent fhe water content fs more than 04 per cent it may be adjusted by adding the calculated amount of acetic anhydride R Storage: protected from light, inimum 15.8 °C ‘Acetic acid, glacial. CJH,0,, (M, 60.1). 1000400, (88-19-7] See Acetic acid, glacial (0590) ‘Acetic acid, 1090401 Content: 290 gi. to 310 gil. of CHO, (6, 60.1) Dilute 30 g of glacial acetic acid to 100 ml. with water R Acetic acid, dilute, 1000402 Content: 115 gil. to 125 gil. of CHO, (M, 80.1) Dilute 12 g of glacial acetic acid to 100 ml. with water R ‘General Notices (0) apply to all monographs and other texts waALA. Reagents EUROPEAN PHARMACOPOEIA 100 ‘Acetic acd, dilute RI. 1000403, Content: 57.5 g/L to 62.5 g/L (M, 60.1) Dilute 6 g of glacial acetic acid to 100 mi with water R Acetic anhydride. C,11,0,. (M, 102.1). 1000500. (108-24-7), Content; minienuma 97.0 per cent mim of CHO, Clear, colourless liquid bp: 136°C to 142°C. Astay, Dissolve 2.00 gin 50,0 ml. of 1 M sodium hydroxide ina ground glass-toppered flak and boil under s reflex condenser for Lh Tittle with 1 M hydrochloric acid using 105 mil. of phenolphthatein solution Ras indicator. Calculate the number of miliitres of 1M sodium hydroxide required for 1 g(n). Dissolve 200 g in 20 mi. of cyclohexane Rin a grosind glass stoppered flask, cool in ice and add a cold fixture of 10m. of aniline R and 20 ml. of eclohexane R. Boil the mixtare under a reflux condenser for 1 h, add 50.0 ml. of IM sodium hydroxide and shake vigorously. Titra with 1M Iaydrochlorie aid, using 05 mol of phenolphthalen solution R abindicator Calculate the nuraber of mililitres of 1M sodium hydroxide required for 1 g(n). Calculate the percentage of CLO, from the following expression. 102(n—m,) Acetic anhydride solution RI. 1000501 Dissolve 25.0 mi of acetic anhyride R in anhydrous pyridine Rand dilate to 100.0 mL with the same solvent Storage; protected from light and at Acetic anhydride - sulfuric acid solution. 1000502, Carefully mix 5 ml. of acetic anhydride R with § ral. of sulfuric acid R. Add Gropwise and with cooling to 50 ml. of ‘anhydrous ethanol R Prepare immediately before use Acetone, 1900600. [67-64-1} See Acetone (0872), Acetonitrile. ¢, cyanide. B Clear, coloures liquid, miseible with water, with acetone and with methanol. a3: about 0.78. LN. (M, 41.08). 1000700, (75-05-8]. Methyl thanensinle 13! about 1.344 ‘A100 gf solution is neutral to tus paper. Disilaton range (2.211). Not es than 95 pe cent dats Between 80 “Cand conte used in spectrophotometry comple withthe felloming ettonal est. “Absorbance (22.25): maximum 0.0 fom 255 nam to 420m, determined Weing water Ras compensation gui. Acetonitrile for chromatography. 1900701 See Acetonitrile R “Acetonitrile used in chromatography complies with the following additional tet. Absorbance (2.2.25): maximum 0,01 at 240 nm and higher ‘wavelengths, determined using water R as compensation guid Content (2228): minimum 99.8 per cent Acetonitrile RI. 1000702, ‘Complies with the requirements prescribed for acetonitrile R and with the following additional requirements Content: minimum 99.9 percent Absorbance (2225): maximum 0.10, determined at 200 am. ‘using water Ras the compensation higsid ‘Acetoxyvalerenic acid. Cy 11,0, (M, 292.4). 1165800. [81397 67°3]. (2B) 3-((ARSASTR7aR) 1-(Acctyloxy) 5,7 dimethyl 2,45,6,7,Pachexabydro-LHTnden-t-j]-2- smethylprop-2-enoic acid, Colourless or ple yellow viscous oi Absorbance (2.2.25). 4 solution in methanol R shows an Absorption maximum at abou 216 nm. Acetylacetamide. C4I,NO,. (M, 101.1), 1102600 (5977-140) 3-Oxobutanamide mp: 53°C to 56°C. Acetylacetone. €.11,0,, (M, 100.1). 1000800, {123-546 2a Pentanedione. CColousless or slighty yellow, easly flammable kigud, freely soluble in water, miscible with acetone, with ethanl (96 per cent) and with glacial aedc aid nbs 145210 1.453, bp: 138°C to 140 °C. Acetylacetone reagent RI. 1000901 To 100 mL. of ammonium acetate slution R add 0.2 mal. of acetylactone R Acetylacetone reagent R2, 1000302, Disgolve 0.2 mal. of aetylactone R, 3 mb of glacal aceite ‘acid Rand 25 g of amsmonsuyn acetate Rin water Rand dilute to 100 mi with the ame solvent, N-Acetyl-e-caprolactam. CyH,.NO,, (Mf, 155.2). 1102700 [188-91-1) NAcetythexane-¢-lactam, CColourless liquid. miscible with anbydrous ethanol AB: about 1.100 13s about 1.489, bp: about 135°C ‘Acetyl chloride. C,H,CIO. (M, 78.5), 1000800. [75-365]. Clear, colourless liquid, Lammable, decomposes in contact swith water and with ethanol (86 per cent, miscible with cthylene chloride 13: abowt 1.10. Distllaon range (2.2.11). Not less than 95 per cent distils between 49 °C and §3 °C Acetylcholine chloride, €,11,CINO,,(M, 181.7). 1001000. {60-31-1) Crystalline pveder, very soluble in cold water and in ethanol (5 per cent) Tedecomposes in hot water and in alkalis, Storage: at = 20 °C, Acetylene. CH, (3, 2604). 1199800. [74-86-2]. Bdhyne Content: miniostmn 99.0 percent VV. Acetyleugenol. C.H,,0, (M2062). 1100700, [93-28 2-Methoxy-1-(2-prepenyl)phenylacetate Yellow coloured, oily liquid, practically inscluble in water, freely soluble in ethanol (96 per cent) pes about 1.522 bp: 281 °C to 282°C. Acetyleugenal uzed in gas chromatography complies with the following additional tex. ‘Assay. Gas chromatography (2.2 28) as prescribed in the ‘monograph Clove eil (1032). Test solution. The substance tobe examined Content: minimum 980 per cent, calculated by the pormalistion procedure N-Acetylglucosamine, C,H, NO, (M,221.2). 1133600 [7512°17-6]. 2-(Acetylamino)-2-deoxy'-glucopyranose ‘mp: about 202 °C ‘See the information section on general monograph (over pages}EUROPEAN PHARMACOPOEIA 10.0 4.11, Reagents Acetyl-11-beto-p-boswellic acid. C,.11,0,. (M, 512.7) 41167700. [67418-61'9}. 3a-(Acetyloxy)-11-oxours-12-en-24 ic acid, (48)-3a-(Acetyloxy)-Il-oxouts-12-en-25-01¢ acid White o almost white poveder, insoluble in water, seluble in acetone, in ankydrous ethanol end in methanol 271 -C 074°C, eyl-L-keto-B-baswellic aid used in liquid chromatography complies with the following additional test. ‘Assay. Ligaid chromatography (2229) as prescribed inthe monograph on Indian frankincense (2310). Content: minimum 90 per cent, calculated by the ormalistion procedure N-Acctylncuraminie acid. Cl, S146), O Sialic acid White of almost white acicular crystals, soluble i water and in methanol, slightly soluble in anhydrous ethanol, practically insoluble in sectone [eB about ~ 36, deter sp: about 186 °C, with decomposition NO, (M, 3083). 1001100. xed om 10 g/L solution, N-Acetyltryptophan. C,,H.N,O, (M, 246.3). 1102800, {218-34-4) 2-Acctylamino'S-{indol-3-yl)propanoic acd White or almost white powder or colourless crystals sighlly soluble in water dissolves in dilute solutions of alkal bydroxides mp: about 205 “Assay. Ligaid chromatography (2229) as prescribed in the monograph Tryptophan (1272), Test solution. Dissolve 10.0 mg in a mixture of 10 volumes of acetonitrile Rand 90 volumes of water Rand dilute to 100.0 ml. with the same mixture of solvents Content: minimum 99.0 per cent, calculated by the normalisation procedure Acetyltyrosine ethyl ester CyH,,NO,H,O. (M, 2693) 1001200. (36546-50-6], N-Aceiy!"-tyrosine ethyl ster monehydrate. Edy] (S)-2-acetamido-3-( bydroxyphenyl)propionate monohydrate White or almost white, crystalline powder suitable for the assay of chymotrypsin [a9 +21 to +25, determined on a 10 g/L. solution in ethanol (88 per cent) R ‘A: 60 to 6, determined a 278 nm in ethanol (9 per enh Acetyltyrosine ethyl ester, 0.2 M. 1001201 Dissolve 0.54 g of aceylironine etl exter Rin ethanol (96 per cent) Rand dilate to 10,0 ma withthe same solvent Acid blue 83. C,11,.N,NaO,S,, (M, 826), 1012200. i108 59 2] Colour Index No. 42660, Brilliant blue. Coomassie briliant blue R250, Brown powder insoluble in cold water, slightly soluble in boiling water and in anhydrous ethanol, soluble in eulfuric acid, glacial acetic acd and in dilute eolstions of alkali hydroxides Acid blue 90, C,11,N,Na0,S,. (M, #54). 1001300. [6104-581]. Colour Index No. 4265. Sodium [4-{[4 [(a-ethoxyphenyD)aminolphenyll{4-ethyD(3 sulfonatobenzyD)amino|phenyllmethyleneleycla-hexs-2, ien-1-ylidene(ehyl)-(3-sulfonatebenzyl)ammonium ‘A dark brown powder, with a violet sheen and some particles having a metalic Tusre, soluble in water and in anhydrous thane 1 gtete than S00, determined 577 nm in 4 001g {cltion in buffer soletion pit 7.0 and eaeuated with fetrence tothe died substance ess om drying (22.32) maxinum 59 per cen, determined on 0300 gy drying in an ovens 103°C Acid blue 92, €,18,.N,Na,O,S, (M, 686). 1001400. {3861-732} Colour Index No. 15380 Coomassie be. Anazolene sodium. Trisodium &-bydroxy-4 (phenjlamino)azonaphthalene’3,5°6-teisulfonate Dark blue crystals, soluble in wate, ip acetone and in ethylene lycol monoethylther, slightly soluble in ethanol (95 per ent). ‘Acid blue 92 solution. 1001404 Disgolve 0.5 g of acid blue 92 Rin a mixture of 10 mL of lacal acetic acid, 45 ra. of ethanol (95 percent) Rand 45 mb of water R Acid blue 93. C11,.NN3,0,S,. (9, 800), 1134200, [28983-56-4 Colour Index No. 42780. ‘Methyl blue. Perrier Bue, Mixture of triphenglrosaniline di- and ‘wiphenylpararosaniline Dark blue povrder. Cotour change: pH 9.4 to pit 14.0, 4, Reagent sulfonate and of ‘Acid blue 93 solution, 1134201 Dissolve 0.2 g of avid blue 93 Rin water R and dilute to 100 mal. with the same solvent «al-Acid- glycoprotein silica gel for chi 1148700. A very finely divided silica get for chromatography consisting of spherical particles costed with al-acd glycoprotein, Acrylamide. C\H.NO, (M, 71.1), 1001500, (79-06-1] Propensmide, CColousless or white fakes oF a white or almost white, cexystalline powder, very soluble in water and in methanol, ffedly soluble in anhydrous ethancl. mp: about 84°C separation, 130 per cent acrylamide/bisacrylamide (29:1) solution. 1001501 Prepare a solution containing 290 g of acrylamide Rand 10 g of methylenebisacrylamide R per ite of water R. Fite. rylamide/bisacrylamide (36.5:) solution 30 per cent 1001502, Prepate a solution containing 292 g of acrylamide Rand & g ‘of metylenebisacrylamide R perlite of water R, Pte. Acrylic acid. CHO, (M, 72.1). 1133700, (79-10-7) Prop-2-enoic acid. Vinylformic aid. Content: minimum 99 per cent kis stabilised with 0.02 per ent of hydroquinone monomethy! ether Corrosive liquid, miscible with water and cthanol (96 per cent) Itpoljmerises readily in the presence of oxygen, a3}: about 1.05. nif? about 1.421 Actein, Cy H,.O,, (M, 677). 1181500, (18642-46-9 (23R.24R,255:368).38-(B-p-Xylopyranosylexy) 169.23:23,26:24,25.tiepoxy 26 hydroxy 8,19 cycolanostan. 128 yl acetate ‘General Notices (0) apply to all monographs and other texts ryALA. Reagents EUROPEAN PHARMACOPOEIA 100 Acteoside. Cyl1,O,, (M, 6246). 1145100. (1276-17 3}, 2-(34 Dibydeoxyphenylethyl 3-0-(6-deony-a-t-mannopyranosy)-4-O-((2E)-3 (at dihydeoxyphenyl)prop-2-enoyl)-B-b-glucopyranoside Verbascoside Light yellowish powder, freely soluble in water and in andl about 140°C, with decomposition ‘Adamantane. Cyl (OM, 1362). 1181600, [281-23-2], fyelo[3 3.1.1 }decane, abot 270°C. Adenine, 1172800, (73-24 See Adenine (0800). Adenosine. CyHyX,0,. (M, 267.2). 1001600. (58-61-7] 6 Amino 9B D-nibofuranosyl S17 purine. White or almost white, crystalline powder, slightly soluble in water, practically inseluble in acetone and in ethanol (96 per cent), Iedissolves in dite solutions of aids sp: about 234 Aipic acid. €,11,0,.(M, 1461). 1095600. [124-049] Prisms, freely soluble in methanol, soluble in acetone, practically inzoluble in light petroleum. about 152 Adrenaline. €.11,.NO,.(M, 1832). 1155000. (51-43-4 GR) 1.6.¢ Dibydeoxypheny)-2-(methylamino ethanol 448) 1 hydrony 2 Unetbylamino}ethylbenzene 12 diol White or almost white powder, gradvaly becoming brown on fxposute to lght and at, very lightly seluble in water and in cthanol (96 pr cent), inscluble in seston. Ie dsolve in dive solitons of mineral acids and lla hydroides. tmp: about 215°C Adrenalone hydrochloride. (nethylamino)ethanone hyrochlorde. 34” Dihydoxy 2 (methylamsino)acctephenone hydrochloride Pale yellow crystals, freely sole in water, soluble in ethanol (86 per cen) about 244°C. ‘Acsein. 1001700, [6805-410] A mixture of related saponins oblained fr ‘Aesculus hippocastanuam L ine, almost white or slightly reddish or yellowish, ami Chromatography. Thin layer chromatography (2.227) Test solution. Dissolve 10 mg of aescin Rip ethanol (70 per cent V/V) Rand dilute to 10m saith the same elven Plate: TLC silica ge plate R Mobile phase: the upper layer of a mixture of 10 volumes of lacal acetic aid R40 volurses of water R and 50 volumes of butanol R “Application: 20. ofthe tet solution as bande of 20 mm by 3mm, Development: over a pth of 12 cm Drying: at 100-105 °. Detection: spray with about 10 mL of anisaldehyde solution R ‘plate 200 mm square and heat again at 100-105 °C. Results the chromatogram shows a principal band with an Ry of about 0.4, 1 seed of Aflatoxin B,- C11,,0,. (Mf, 12.3). 1166000 162.65-8} (628,935) 4 ethoxy. 2,363,88tetrahydro eyelopentalelturo{s".2°4.5}urol2,3-Al[LJbenzopyrat- 1,11 White or fain yellow crystals ‘Agarose/cross-linked polyacrylamide. 1002200. ‘Agarose trapped within a crot-linked polyacrylamide ietwork; ti used forthe separation of globular protein with felative molecular masses of 2 10°10 35 x 10% ‘Agarose-DEAE for ion-exchange chromatography. 1002100. (57407-08-6 Crosslinked sgarote rubstituted with diethyleminocthyl groups, presented as beads, Agarose for chromatography. 1001800, [9012-36-6] Swollen beads 60:140 jm in diameter presented as a4 per cent suspension in water R. ‘Used in size-exclusion chromatography forthe separation of, proteins with relative molecular masses of 6 10°10 20% 10° dof polysaccharides with relative molecular mastes of 3x10" 5x10 Agarose for chromatography, cross-linked, 1001900. {e1870.08-9) Prepared from agarose by reaction with 2,3-dibromepropancl in strongly alkaline conditions Tt occurs as swollen beads 60-140 um in diameter and is presented as a 4 percent euspension in water R ‘Used in size-exclusion chromatography forthe separation of proteins with relative molecular arses of 6 10° to 20 10° nd of polysaccharides with relative molecular masses of Sx 10"to 3% 10" Agarose for chromatography, cross-linked RI. 1001901 {65089-78-8) Prepared for agarose by reaction with 23-dibromopropanel in strongly alkaline conditions 1 occurs as swollen beads 60-140 um in diameter and is presented as a4 per cent euspension in water R Used in size-exclusion chromatography for the separation of proteins with relative molecular matics of 7 10°10 40 10° nd of polysaccharides with relative molecular masses of Tic 0"t0 2 10" Agarose for electrophoresis. 1002000. [9012-36-6 ‘A neutral, linear polysaccharide, the main component of ‘which ie derived from agar ‘White or almost white powder, practically insoluble in cold water, ery slightly soluble in hat water, Agnuside. C.H..0,. (M, 466.4), 1162000, (11027-63-7)" (1S 4aSR,SR5,7aRS)-5-Hydrony 7 [[(4hydroxybenzoyl)oxy}methyl}-145,70 tetrabydrocyclopentafejpyran-1-jl P--giveapyranoside White o almost white crystal, Ai, hydrocarbon-free. 118870. Complies with the requirements presribed forthe monograph Medicinal air (1238) withthe following additional requirement Hydrocarbons: maxiowum 5 ppm V/V, caleulated as CH, Alanine, 1102900. [36-41-71 See Alanine (0752) B-Alanine. 1004500, (107-95-9 See J-aminopropionic acid R Albumin, bovine. 1002300, [9048-46-8) Bovine serum albumin containing about 96 per cent. ‘White to light brownish-yellow powder. Water (25.12)- maximum 3,0 per cet, determined on 0.800 g, Allumin, bovine RI, 1183500, [9048-468 Bovine serum albumin containing about 96 per cent. White or light brownish yellow powder protein ‘See the information section on general monograph (over pages}EUROPEAN PHARMACOPOEIA 10.0 4.11, Reagents Albumin, human. 1133800. ‘Human serum albumin containing not less than 96 percent of albumin, Albumin solution, human. 1002400. [9048-46-8] See Huan albumin solution (0285) Albumin solution, buman Ri, 1002401 Dilute human albunnin solution R with a9 gil. solution of soudura chloride R toa concentration oft gil of protein ‘Adjust the pH to 3.5-4.5 with glacial acetie acid Alcohol, 1002500. [64-17-5) See Ethanol (96 percent) R Alcohol (x percent V/V). 1002502. See Ethanol (x per cent VIV) Alcohol, adehyde-free. 1002501 ‘Mix 1200 mL of ethanol (96 percent) Rwith 5 mL of a 400 git solution of silver nttate R and 10 mL oft cooled '500 g/L solution of potassium hydroxide R Shake, allow to stand for a few days and filter. Dist the Slate immediately before use Aldehyde dehydrogenase, 1103000. Enzyme obtained from baker's yeast which oxidicet acetaldehyde to aceic acid in the preeence of icolinamide adenine dinudeotide, potassium salle and thiol, at pH 8.0, Aldehyde dehydrogenase solution. 1103001. Dissolve in water R a quantity of aldehyde dehydrogenase R, ‘equivalent :0 70 unit and dite to 10 ml. with the same solvent This solution is stable for # hat °C. cl, (M, 3648). 1123100, [308-00-2] bp: about 145 °C sp: about 104°, A suitable certified reference solution (10 ng/u in cyclohexane) may be used. Aleuritic acid. CyH,.0,, (M, 3044). 1095700, [533-87-9] (ORS 108R)-9,10,16-Tribydroxyhexadecanoie acid White or almost white powder, greasy tothe touch, soluble sa methanol sp: about 101 Alizarin S.,.H,Na0,S.H,0. (6,360.3) 1002600. (130-22-3) Sebltz No. 1145. Colour Index No. 58005 Sodium 12-dikydroxyanthraquinone-3-su monohydrate. Sodium 3,4-dibydrony-8,10-dioxo-9,10 hydroanthracene-2-sulfonate monohydrate COrange-yellow povrder, rely soluble in water and in ethane! (98 per eens) Alizarin § solution, 1002601 AL gil sal Test for sensitivity Walizarin § solution is used fr the standardisation of 005 M barium perchlorate, i shows 4 colour change from yellow to orange-red when iis Tested according tothe standardisation of 0.05 M barius perchlorate Colour change: pH 3.7 (yellow) to plt 52 (viol Aloe emodin, C10, (M, 270.2). 1188800. [481-721]. 1,8-Dihydroxy-3-(hydroxymetbylJanthracene-9,10-dione 1.8-Dihydeoxy-5-(hydroxymethyl}anthraguinone don ofalizarin $ R Alovadine. Cyll)FN,0,.(M, 2442). 1185490, [25526-93-6] 1-{GR4S3R)-4-Flooro:5-(hydeoxymethy!)etrahydrofuran 2-yl-5-methyipyrimidine-24(L71,2)-done, Huorodeexythymidine, 5” Deoxy-¥-fvorothymidine. tent: minimum 95 percent. Colourless crystals Aluminium. Al (A,26.98). 1118200. [7428-80.5]. ‘White or almost white, malleable, exible, bluish meta. avalable as bars, sels, powder, strips or wire. In mois air an ‘oxide lm forms which protects the metal from corrosion, ‘Analytical grade Aluminium chloride. AICI, 612.0. (M, 241.4. 1002700. (7784-13-6) Aluminium chloride hexahydrate Content: minimum 98.0 percent of AICI, 61,0. ‘White or slightly yellowish, crystalline povedes, hygroscopic, freely soluble in water and in ethanol (85 per cent) Storage: sn an siptight container, Aluminium chloride reagent. 1002702 Dissolve 20 g of alumsiniuns chloride Rin 100 mi of a5 per ‘ent V/V solition of glacial acetic acid Rin methanol R 4, Reagent ‘Aluminium chloride solution, 100270. Diseove 65.0 g of aluminium chloride Rin water R and ‘ilu to 100 ml. with the same solvent, Ada 05 g of ‘activated charcoal R, si for 10 ai, filer and add to the filate, with continuous sting, sufficient of a 10 g/L solution of sodium hydroxide (about 60 mL) to adjust the pH t about 15. Aluminium aiteate, AI(NO,),9H,0. (M, 375.1}, 1002800. (778427 2}. Aluminium nitate nonahydrate Cysts, dliquescent, very soluble in water and ethanol (6 per cent) very slightly soluble in acetone Storage: in an airtight container, Aluminium oxide, anhydrous, 1002900. (1344.28-1] ‘Aluminium oxide, consisting of y-ALO, dehydrated and sctivated by heat ieatment article sce: 75 unto 150 ym. ‘Aluminium oxide, basic. 1118300 'A basic grade of anhydrous aluminium oxide R suitable for ‘column chromatography. ‘pH(22.3). Shake 1 g with 10 ml of carbon dioxidefree water Rfor 5 min. The pH ofthe suspension is 9 to 10. Aluminium oxide for chromatography, deactivated. 1188900. ‘Aluminum oxide suitably deactivated forthe separation and {election of traces of polar hydrocarbons, wath porous layer ‘open tubular (PLOT) desiga. Aluminium oxide, neutral. 1118400. See Aluminium oxide, hydrated (0311), Aluminium potassium sulfate. 1003000, (7784-249) See Alun: (0008) Aluminium test strip, 1199500, ‘Commercially available test sri forthe determination of sluminium in aqueous solvents a¢ level below 5 ppm, Americium-243 spiking solution. 1167500, Contains 50 Ba/l. Am and a 134 mg. solution of lanthanuoe chloride heptahy rate R in 103 g/L solution of hydrochloric cid B ‘Amido black 108, C,,.N.NA,0,S, (M, 617), 1003100, {hos4-8-3). Schultz No, 298 Colour Index No, 20470, ‘General Notices (0) apply to all monographs and other texts aALA. Reagents EUROPEAN PHARMACOPOEIA 100 Disodium 5-amino-s-hydroxy-6-[(4-nitrophenyi}szo]-3 (phenylazo)naphthalene 2,7 disulfonae, ask brown to black powder, sparingly soluble in water, soluble in ethanol (96 per cen). ‘Amido black 108 solution, 1903101 AS giL-solution of amido black 108 R in a mixture of 10 volumes of acetic acid R and 90 volumes of meth Aminoazobenzene. C,11,.Ny (M, 1972). 1003200. 60-093}. Colous Index No. 11000 4-(Phenylazo)aniline Brownish yellow needles with a Sluish tinge, slightly soluble tn wale, feey Soluble in ethanel (96 per cent). sp: about 128 °C 2-Aminobenzoie acid. CH.NO,. (3,137.1), 1008400, {1s-92-3]- Antheanlic acid ‘A white or pale-yllow, crystalline powder, sparingly soluble tn cold water freely soluble in hot wate, in ethanol (86 per cent) and in glyerol, Solutions in ethanol (96 percent) or in ether and, paruculaly, in glycerol show a viele uoreseence show 145“ 3-Aminobenzoic acid. CH,NO, {98-05-8} White or almost white crystals, An aqueous sletion torns brown on standing in aie sp: about 174 °C, Storage: in an airtight cont 4-Aminobensoic acid. GHNO, {is0-13 of White or almost whit, crystalline powder, sigh soluble in water, rely slube in anol per cen, practically ucluble in ight petroleum. mp: about 187°C Chromatography. "Thin layer chromatography (2.2.27) a8 preserbed inthe monograph Procaine hy achive 0050) the chromatogram shows only one prinlpl spot Storage: protected from light 4-Aminobenzoic acid solution. 1003301 Dissolve 1g of 4-aminobenzoic acid Rin a mixtore of 18 ml. of anhyurous acetic acid R, 20:1 of water Rand 1 mal of ‘phosphoric acid R. Immediately before use, mix 2 volumes ff the solution with 3 volumes af acetone R N-(4-Aminobenzoyl)-1-glutamic acid. (ha 2663). 1111708 ahi 301) ADGA SI ‘Aminobenzoyl)aminolpentanedioic acid, White or almost whit, crystalline powder, sp: about 175 °C, with decomposition. 4-Aminobutanoic acid. C,,NO,. (M, 108.1). 1123200. {56-12-2], y-Aminebutyric add. GABA. Leaflets from methanol and ether, needles from water and ethanol (96 per cent), Freely soluble in wate, practically, insoluble or slightly soluble in other solvent. sp: about 202 °C (decreases on rapid heating) Aminobutanol. C,H,NO. (Mf, 89.1), 1003500. [5856-63-3]. Aminochlorobenzophenone, C,,ih,CINO. (M, 231.7) 1003600, [719-59°5].2-Amino-5'chlorobenzaphenone Yells, crystalline powder, practically insoluble im wate, freely soluble in acetone, soluble in ethanol (95 percent) p> about 97 °C Content: minimum 95.0 per eent Storage: protected from light 4-Aminofolic acid. C,1,N,O, (M, 440.4). 1163700. (54-62-6), (25)-2-{(-[{.4-Diaminopterdin-6- 'methyljamino]benzoyljamino|pentanedioic acd N-(4-[(0.4-Diaminopteridin-6-ymethyllaminolbenzoyl]-1- lutumic acid. Aminopterine Yellowish powder. mp: about 230 6-Aminohexanoic acid, [60-32-2] CColousless crystals, esl soluble in water, sparingly soluble sn methanol, practically insoluble sn anhydrous ethanol mp: about 205 °C Clty NO,, (M, 1312}. 1103100. Aminohippuric acid (194.2). 1003700 [61-78-9]. (4-Aminobenzamido)acetic acid ‘White or almost white powder. sparingly soluble in water, soluble in ethanol (86 per cent) mp: about 200 °C Aminohippuric acid reagent. 1003701 Disgolve 3 g of phthalic aid R and 03 g of aminokippurie acid Rin ethanol (96 per cent) Rand dilute to 100 mk. with the same solvent, Aminohydroxynaphthalenesulfonie acid. C,H,NOS. (af, 239.3). 1112400. (116-632). 4-Amino-> bbydvoxynaphthalene-L-sulfonic acid. ‘White or grey needles, turning pink on exposure to light, especially when moist practieally insoluble in water and in ethanol (96 percent), soluble in solutions of alkali hydroxides nd in hot solutions of sodium metabisulate, Storage: protected from ight, Aminohydroxynaphthalenesulfonic acid solution 12401, Mix 5.0 g of anhydrous sodium sulfite R with 943 g of sodium hydrogensulfite Rand 07 g of amsinohydroxynaphthalenesulfonic aid R. Dissolve 15 g of the mixture in water Rand dilute to 10.0 mL. with the same solvent, Prepare the solution dally. ‘i Aminoindanol, C,15,NO. (M, 149.2). 1168300. [126456-48-7)- (15.28)-1"Amino 2.3 dibyéro 1H inden 2-0 (Q)-cis1-Aminoindan-2-0l Content: minimum 98.0 per cent (sum of enantiomers, determined by gas chromatography) cf: ~ 69 to ~ 59, determined on 2 g/L solution in ® chloroform R. mp: 118 122°C, Aminomethylalizarindiacetic acid. C,11,.NO,211,0. (4,421.4), 1003900, [3952-78-1]. 2.2 [(.4-dihydroxy. anthraquinon-3-yl)methylenenitelo}diacetic acid dibydeate Alizarin complexone dihydrate Fine, pale brownish-yellow or orange-brown powder, ‘wate, soluble in solutions of alkali mp: about 185 °C Loss om drying (22.32): maximum 10.0 per cent, determined fon 1000 g ‘See the information section on general monograph (over pages}EUROPEAN PHARMACOPOEIA 10.0 4.11, Reagents Aminometbylalizarindiacetic acid reagent, 1003901 Solution A, Dissolve 0.36 gof cereus nitrate Rin water R and dilute to 50 mal. with the same solvent Solution B. Suspend 0.7 g of aminomethylalizarindiacetc ‘acid Rin 50 ml. of waterR, Dissolve with the aid of about 0.25 mL of concentrated ammonia R, add 0.25 ml. of lacie ‘etic acid R and dite to 100 a with water R lution C, Disslve 6g of sodium acetate Rin $0 ml. of water R,add 115 mb. of glacial acetic acid R and dite to 100 ml. with water R. "To 33 ml. of acetone R add 6.8 mL. of toluion C, 1.0 mb of solution B and 1,0 mal. of solution A and dilute to 30 aL with water & Test for sensitivity, To 1.0 ml. of fluoride standard solution (10 ppm F) R add 19.0 mL of water R and 5.0 ma the aminomethylaizarindiactie acid reagent. After 20 in, the solution assumes a blue colour Storage: se within 5 aye, Aminomethylalizarindiacetic acid solution. 1003902, Dissolve 0.192 g of aminomethylabizarindiacetic acid R {in 6 rl. of freshly prepared 1 M sodiwy hydroxide. Add 750 ml of water Re 25 ml. of sucinate bugfer elution plLL6 R and, droporise, 0.5 M hydrochloric avid wnt the ‘colour changes from violet red to yellow (plT 45 to 3). Add 100 mt. af acetone R and diate to 1000 ma. with water R 4-Aminomethylbenzoie acid. 1167800. (56-1-7. “HNO, (M, 181.2), Aminonitrobenzophenone. C,H.N,0,. (M, 2422) 1004000. [1775-8547], 2-Amino”s-nittobenzophen: ‘allow, crystalline powder, practically incoluble in water, soluble in tetrahydrofuran, sighly soluble in methanol sp? about 160 °C Aj: 690 to 720, determined al 253 am using a 001 g/L olution in methanol R 6-Aminopenicillanie acid. C,11,.N,O\S. (4,216.3). 1162100. 551. 16-6) (25,5R,6R)-6-Amino'3,3-dimethyl-7-oxo-4-thia Fazabieyelo[3.2 0]heptane-2-carboxylic acid Appearance: white or almost white powder: mp: about 205 with decomposition Aminophenazone. C,!1,.N,O. (2313). 1133900. [58-15-1] 4 (Dimethylamino}-15 dimethyl 2-phenyl-1.2-dihydro. 3H pyrazol Sone White or almost whit, crystalline powder or colourless crystals, seluble in water, Heely soluble in ethanol (86 per een. host 108°C. 2-Aminophenol. C1,NO. (M, 109.1). 1147500. [95-55-6] Pale yellowish-brovwn exytals which rapidly become brown, sparingly soluble in wate, soluble in ethanel (96 per cen. about 172°C. Storage: i an actght container, protected from light. 3-Aminophenol. C,,NO. (Mf, 109.1). 147600, [391-27-5) Pale yellowish-brovn crystals, sparingly soluble in wat rps about 122 °C, 4-Aminophenol. C1LNO. (, 109.1), 1004300, (123.308 Content: mintonur 95 per ce White ot slightly coloured, erytalline powder, becoming coloured on exporure to air and light, sparingly soluble in water, soluble in anhydrous ethanol host 186°C, ith decomposition Storage: protected from light Aminopolyether. Cy1l,.N,0,, (M, 376.5). 1112500, [23978-09-8]. 47,13,16,31,24‘hexzoxa-1 20 diazabicyclo(a.8.s)hexacosane mp: 70°C to 73°C. 3-Aminopropanol. C.1i,NO, (M, 75.1). 1004400, [156- 3-Aminopropan-L-ol. Propanclamine (Clear, colourless, viscous liquid. 2}: about 099, 133; about 1.461 amp: about 11° 3-Aminopropionic seid. C,H.NO,,(M, 89.1), 1094500 {107-959} prAlanine Content: nim 99 per cent White o almost white crystalline powder, rey solble in water, slightly soluble in ethanol (96 per cent), practically insoluble in acetone, ‘mp: shout 200 °C, with decomposition, Aminopyrazolone. Cy 11,.N,O. (3,203.2). 1004600. [33-07-8]. 4-Amino-23-dimethyl- phenylpyrazolin-5-one Light-yellow needles or powder sparingly soluble in water, freely soluble im ethanol (96 per cent) mp: about 108 °C 4, Reagent Aminopyrazolone solution. 1004601 AL gif. solution of aminopyrazolone Rin bufir solution pHSDR 3-Aminosalicylic acid. C.1L.NO,. (M, 153.1). 1183600. [570-23-0}, 3 Amino-2 hydeoxybenzose acd mp: about 240 °C Slighlly soluble in water. 4: Aminosalicyli acid. C,H,NO,, (M, 153.1), 1183700, [65-19-6], 4-Amino-2-hydroxyhenzoic acid White or almost white, bulky powder, slighty soluble in water, soluble in ethanol (96 percent), in dilute nitric acid and in odium hydroxide. It darkens on exposure to air and light mp: 135°C to 15°C, Storage: ata temperature not exceeding 30 °C, in an airtight container, protected from light Ammonia, concentrated. 1004700, See Concentrate ansmonia solution (0877) Ammonia, 1004701 Content: 370 gil to 380 gil of NH, (M, 17.03) Dilute 67 g of concentrated ammonia R to 100 mL with water R AB. 9.931 19 0934 When used inthe ts for iron, ammonia R complies with the following additional requirement. Evaporate 5 ml. of ammonia to dryness on a water-bath, add 10 ml. of water R 2m. of «200 g/L solution of citric acd monohydrate R and 0.1 mi of thioglycolic acid R. Make alkaline by adding manonia Band dilute to 20 ra. with water R.No pink colour develops Storage: protected feom atmospheric carbon dioxide, at a temperature below 20 °C Ammonia, dilute RI. 1004702. Content: 100 gi. to 104 gil of NH, (M, 17.03). Dilute 41 of concentrated ammonia R to 100 ml. with water Ammonia, dilute R2. 1004703 Content: 33 g/L to 35 g/L of NH, (M, 17.03). Dilute 14g of concentrated ammonia R (o 100 mL with water R ‘General Notices (0) apply to all monographs and other textsALA. Reagents EUROPEAN PHARMACOPOEIA 100 Ammonia, dilute R3. 1004704 6 g/l-to 18 gil of NH, (M, 17083), Dilute 07g of concentrated anmionia Ro 100 ml. with water R Content: Ammonia, dilute Rt. 1003706 Content: 8.4 giL to 86 gL of NH, (M, 17.03), Dilute 35g of concentrated ammonia R to 100 ml. with water R Ammonia, lead-free, 1004705, ‘Complies with the requirements prescribed for dilute ‘ammonia RI with the following additional test: 20 mL. fof lead-free ammonia, ad | mb of lead free potassium ‘yanide solution R, dite to 30 aa with water Rand add 0.10 ma of sodium sulfide solution R The solution is not amore intensely coloured than a reference solution prepared. ‘without sodium sulfide Ammonia, concentrated RI. 1004800. Content: minimum 30.0 per cent mim of NH, (M, 17.03) A dear, coloutless liquid <4} ess than 0.892. Assay, Weigh accurately a ground gla stoppered flask ‘containing $0.0 ml. of 1 M hydrochloric acid. Intcoduce 2 ml, of concentrated animonia RI and weigh again, Titrate the solution with 1M sodium hydroxide, sing 05 ml. of methyl ed mized solution Ras indicator L of 1 M hydrochloric acid is equivalent to 17.03 mg of NA, Storage: protected from atmospheric carbon dioxide, at a cemperatore below 20°C, Ammonium acetate. C.INO, (M, 7.1), 1004900 {ea1-el-8] Colourless crystals, very detiguescent, very soluble in water asd in ethanol (96 per cen). Storage: i an airtight container, Ammonium acetate solution, 1004801 Dissolve 150 g of ammonium acetate Rin water R. Add 3 mb of glacial acetic acid Band lute to 1000 mL. eth water B Storage: se within 1 week, ‘Ammonium and cerium nitrate. (NH),¢ (a, 548.2. 1005000. [16774-21-3] Orange yellow, crystalline powder, or orange transparent crystal, soluble in wate, (NO), Ammonium and cerium sulfate. (NH),Ce(S0,),21,0. (a, 633). 1005200, [10378-47-9]. Orange yellow, crystalline powder or crystals, slowly soluble (18)-(-)-Ammonium 10-camphoreulfonate {,219.3). 1103200, Content: minimum 97.0 percent of (1R)-(-)-ammo: 10-camphorsulfonate. {a — 18 2, determined on a 50 g/L solution iFhyNOS. ‘Ammonium carbamate, CH.N,O,, (M,78.0 111-780) Cazbamse acd ammonium sal, 1188400, Ammonium carbonate, 1005200. [506-87-6]. A. ‘mixture of varying proportions of ammonium hydrogen ‘atbonate (NH,HCO, M, 79.1) and ammonium carbamate (NH,COONH,.M, 78.1). White or almost white tranelucent mats, slowly soluble in bout 4 parts of water. Tcis decomposed by boing water “Ammonium carbonate iberates not less than 30 per cen m/e of NH, (M, 17.03), ‘Assay. Dissolve 2.00 gin 25 ml. of water R, Slowly add 50.0 rl Of M hydrochloric acid, utrate with 1M eodiunn hydroxide, ‘sing 0. mi. of methyl orange solution Ras indicator 1 mL of 1 M hydrochloric acid is equivalent to 1703 mg of NH, Storage: a a temperature below 20, Ammonium carbonate solution. 1005201 {A.158 gi. solution of ammonium carbonate R ‘Ammonium carbonate rolution RI. 1005202. Dissolve 20g of ammonium carbonate Rin 20 axl of dilute ‘annmonia RL and dite to 100 mL with water R Ammonium chloride. 1005300. (12125-02-9] See Ammonium chloride (0007), Ammonium chloride solution, 1005301, ‘A 107 giL lution of ammonium chloride R Ammonium citrate. C,H,,N,O, (M,2262}. 1103300, {3012-65-5}. Diammonium hydrogen citrate. White or almost white crystalline poveder or colourless crystals, freely soluble in water, slighty soluble in ethanol (Sb per cent) pH (22.3); about 43 for a 22.6 gf solution, Ammonium dihydrogen phosphate. (NHJH,PO, (3,115 0). 1005400. {7722-76-1], Monobasie ammon phosphate, ‘White o almost white, crystalline powder or coloutless crystals, eely soluble in water pIT(2.2.3): about 42 for 223 g/L solution, ‘Ammonium formate. CH.NO,, (M, 63.1), 1112600, {s40-69-2] Deliguescent crystals or granules, very soluble in water, soluble in ethanol (96 per cent) mp: 119°C to 121°C. Storage: in an airtight container, Ammonium hexafluorogermanate(IV). (NH). Ge, (af, 2227). 1134000. [16862-47-3]. ‘White or almost white crystals, freely soluble in water. Ammonium hydrogen carbonate, NE,HCO,. (Mf, 79.1). 1005500, (1066-33-7), ‘Content: minimum 99 per cent Ammonium molybdate. (NH).Mo,O,, 44,0. (M, 1236) 1905700, (12084-85- Colourless or slightly yellow or greenish crystals, soluble in water, practically insoluble in ethanol (96 per cea). Ammonium molybdate reagent. 1005701, Mix, inthe given order, 1 volume of 25 g/L solution of ‘aminonivin molybdate BL volume of «100 gi. slution of lascorbic acid R and 1 volume of sulfuric acd R (294.5 glL HSO)) Add 2 volumes of water R Storage: use within 1 day. Ammonium molybdate reagent RI. 1005706. Mix 10 mL. of a 60 g/L solution of disodium arsenate R, 50 mi of arnmonium malybaatecoluion R, 90 mal of dilute Sulfuric acid R and dite to 200 min eater R Storage: in amber asks a 37 °C for 24h, ‘See the information section on general monograph (over pages}EUROPEAN PHARMACOPOEIA 10.0 4.11, Reagents Ammonium molybdate reagent R2. 1005708. Dissolve 50 g of ammonium molybdate Rin 600 mL. of water R Yo 250 mal. of cold water R add 150 ml. of sulfuric ‘aid R and cool. Mix the 2 solutions together. Storage: use within T day Ammonium molybdate solution. 1005702. ‘4.100 gil solution of ammonium molybdate. Ammonium molybdate solution R2. 1005703, Dissolve 50 ¢ of animorium molybdate R with heating i 30 sab of water R Cool, adjust the pH to 7.0 with dilute ‘animonia R2 and dilute to 50 mL. with water B. Ammonium molybdate solution R3. 1005704, Solution A, Dissolve 5g of ammonium molybdate Rin 2O mal of water R with heating Solution B, Mix 130 ml. of ethanol (95 percent) R with 150 ml. of water R.Add with cooling 100 ml. of sulfuric acid R Immediately before use add 80 volumes of solution B to 20 volumes af saution A. Ammonium molybdate solution RA. 1005705, Dissolve 1.0 g of ammonium molybdate Rin water R and dilate co 40 ral. with the same solvent. Add 3 mi of Iiydrochlorie acid Rand $ ml. of perchloric acid R and dilute 10 100 ml with acetone Storage: protected from light; use within 1 month. Ammonium molybdate solution RS. 1005707, Dissolve 1.0 g of ammonium melybdate Rin 40.0 ma. of 15 per cent V/V solution of sulfuric aid R. Prepare the solution dal, Ammonium molybdate solution R6. 1005708, Slowly add 10 ml of sulfuric acid K to about 40 mal. of ‘water B Mix and allow to cool, Date to 100 mb. wth ‘ater Rad mix. Add 25 g of ammonium molybdate Rand Tig af cerium sulfate R, and shake for 15 min to dissolve Ammonium nitrate. NH,NO,. (0M, 0.0). 105800 {484-52-2) White or almost white, crystalline poveder or colourless crystals, hygroscopic, very soluble in wate, freely soluble in ‘ethanol, soluble in ethanol (96 per cent) Storage: in an airtight container Ammonium nitrate RI, 1005801, ‘Complies with the requirements prescribed for ammonium nitrate R wath the following addtional requirements, Acidity: The solution ofthe substance is slighty acid (22. Chlorides (2.4.4): maximum 100 ppm, determined on 050g. Sulfates (2.4.13): maxiewum 130 ppm, determined on 1.0 g Sulfated ash (24.14): maximum 0.05 percent, determined on 10g, Ammonium oxalate. 11,N,0.11,0. (M, 142.1). 1005800. 6008-70-71 CColourless crystals, soluble in water Ammonium oxalate solution, 1095901 A.40 gil solution of anomonium oxalate R Ammonium persulfate, (NH);8,0, (M, 228.2). 1006000 (7727-54-0) White or almost white, frely soluble in water talline powder or granvlar ystal, Ammonium phosphate. (NIL)1PO, (M, 1321), 1006100, [7785-28 0}. Dismmoniom hydrogen phosphate White or almost white crystals or granules, hygroscopic very soluble in wate, practically insoluble sn ethanol (96 per cent. ‘pH(2.2.3): abot 8 for 4200 gi. solution, Storage: in an sirtght container Ammonium pyrrolidinedithiacarbamate. C,H,.N.S, (M, 1643). 1008200. (5108-86-3]- Ammonium 1 pyrroldinyl-dithioformate. White or pale yellow, crystalline powder, sparingly soluble in water, very slightly soluble in ethanol (86 per cent) Storage: is a bottle containing piece of ammonium carbonate ina muslin bag. Ammonium reineckate, NI1,[Cx(NCS),(NI)] (Mf, 354.4) 1008300. (13573-16-5]. Ammonium iaisine-tetraks(sothiocyanatochromate(TD) monohydeate Red power or crystals, sparingly soluble i cold wate, soluble in hot water and in ethanol (86 per cent), 41. 4, Reagent Ammonium reineckate solution. 100630. ‘A.10 gl solution of ammonium reineckate R. Prepare immediately before use. ‘Ammonium sulfamate. Ni (7773-06-0) White of almost whit, crystalline poeder or colourless cexystals, hygroscopic, very soluble in water, slightly soluble in ethanol (96 perce mp: about 130 °C Storage: sn an airtight container, ), 100600 Ammonium sulfate. (NH),SO, (0 (7785-20-2}. CColousless crystals or white or almost white granules, very soluble in water, practically insoluble in acetone and in ethanol (6 per cent pit (22.3): 45 to 60 for 250 gi. solution in carbon ‘oxide free water R Sulfate ash (2.4.14): maximum 0.1 percent Ammonium sulfide solution. 1123300. Saturate 120 ml of dilute ammonia RI with hydrogen sulfide R vd add 80 ml. of dilute ammonia RI, Prepare immediately before wee, ‘Ammonium thiocyanate. NH,SCN. (M, 76.1). 1006700. [1782-95-4) Golourless crystals, deliquescent, very soluble in wate, soluble sn ethanol (96 per cent) Storage: in an attight container, 32.1), 1006500, Ammonium thiocyanate solution. 1006701 ‘A76 g/L solution of ammonium thiocyanate . Ammonium vanadate. NH.VO,, (3, 117.0), 1006800, [7803-55-5). Ammonium trioxovanadate(V}). White or slightly yellowish, crystalline powder, slightly soluble in water, Soluble in dilute ammonia RL Ammonium vanadate solution, 100880. Dissolve 1.2 of ammonium vanadate Rin 95 ml. of water Rand dite to 100 mt with sulfuric acid R Amoxicillin trihydrate, 1103400 See Amoxil trihydrate (0260). a-Amylate, 1100800, 14-0-D-glucane-glacanohydrolase (ec 321 White or light brown powder Amylase solution. 1100801 solution of e-amylase R with an activity of 00 FAUT. ‘General Notices (0) apply to all monographs and other texts ~ALA. Reagents EUROPEAN PHARMACOPOEIA 100 B-Amyrin. Cyll,0. (M, 426.7). 1141800. (558-70-6] Olean 12-en 38-4 ‘White or almost white powder. mp: 187 °C w 190°C Andrographolide, C,,H1y0,. (M, 350.4). 1198100. '508-38-7]. (3FsAS)-[3-(ARAaS SRR 835) 6-Hydroxy-5-(hydroxymiethyi)-5.aa-dimethyl-2- sethylenedecabydronaphthalen-1-yethylidene bydeoxyihydrofuran-2(3H)-one. Anethole. C,11,0. (M, 148.2). 1008800, [4180-23-8 1-Methoxy-4'propen-1-ybenzene White or almost white, erytaline mass up to 20°C to 21 liguid above 23 °C, practically insoluble in water, freely soluble smanhydrous ethanol, soluble sn ethyl acetate and in light petroleum, 3: about 1.56. bp: about 230°C Anethole used in gas chromatography complies with the following additional test ‘Asiay, Gas chromatography (2.2.24) as prescribed in the aonograph Anite ol (0804). Tea! solution, The substance to be examined Content; minimum 99.0 percent of trans-anethole (eetention time: about I min), calculated by the normalisation procedure Anhydrous colloidal silica, 1202000, (7631-86-9] See Anhydrous colloidal silica (0434). Aniline. CN. (M, 93.1), 1007100, (62-58-3}. Eenzeneamine. CColousless or slighty yellowish lguid, soluble in water, siseible with ethanol (96 pet cent), about 1.02, bp: 183 °C to 186°C. Storage: protected from light. Aniline hydrochloride. ©,H,CIN.(M, 128.6). 1147700. {142-04-1]- Benzenamine bydrochloride Crystals Ti darkens on exposure to air and ight, 1 about 198 °C, Storage: protected from light Content: minimum 97.0 percent. Anion-exchange resin, 1007200. Resin n chlorinated form containing quaternary ammonium oups [CHN'(CH),]atached to wpalyer lace consisting tpolystyrene cost linked with 2 pe cent of divinylbenzene Iuib avaiable a spherical beads ‘Wash the resin with 1 zodium hydronide oma sintered-plase Site 40) (2.12) una the washings ar ec from chloride, thn wash eth water snl the washings are nevte Soupend in freshly prepared ammonium water Rad protect from atmospheric eatbon donid nion-exchange resin RI. 1123400. Resin containing quaternary ammonium groups {CH,N'(CH,)] attached to alatice consisting of methacrylate Anion-exchange resin R2, 1141900, Conjugate of homogencous 10 ums hydrophilic polyether particles, and a quaternary ammonium sal, providing a ix suitable [or sizong anion-exchange ‘Anion-exchange resin BS. 1180300. Resin with quaternary ammonium groupe attached to & Iattice of ethylvinybenzene crosslinked with 55 per cent of ivinylbenzene Anion exchange resin for chromatography, strongly basic. 1112700. Resin with quaternary amine groups attached to a lattice of Iatex cross inked with divinybenzene. Anion-exchange resin for chromatography, strongly basic RI. 118740. [Non-porous resin agglomerated with a 100 nm alkyl {goalernary ammonitm functionalized latex. ‘Anion-exchange resin for chromatography, strongly baste R2. 1203000. Non: porous resin agglomerated with a 43 nm ‘quaternary amine fanctionalised latex, exoss linked ‘with ethylvinylbenzene!divinybenzenc. Anion-exchange resin, strongly basic. 1026600. Gel-type resin in hydroxide form containing quaternary ammonium groups [CH,N"(CH,), type 1) attached to 2 polymer latce consisting of polystyrene croge linked with Sper cent of divinyloenzene. Brown transparent beads Particle sce: 0.2 man to 1.0 ma, Moisture content: about 50 percent, Total exchange capacity: minimum 1,2 meq/ml, Anion-exchange resin, weak. 1145700, Resin with diethylaminoethyl groups attached to a lace consisting of ply(methyl methacryate), Anisaldehyde. C,H,0,,(M, 136.1), 1007300, (128-115) ‘4 Methorybenzaldehyde, ily Ligui, very slighty soluble in water, miscible with ethanol (95 percent). bp; about 248 °C. Anisaldehyde used in gas chromatography complies withthe following additional txt, ‘Assay, Gas chromatography ( ‘ronograph Anise ol (0804), Teat solution. The substance to be examined. Content: minimum 98.0 per cent, calculated by the normalisation procedure Anisaldehyde solution. 1007301, ‘Mix in the following order 0.5 ml. of anisaldehyde R, LW tat of glacial acetic ach , 85 en. of methanol R and Smal of sulfuric acid R Anisaldehyde solution RI. 1007302, ‘To 10 ml of anisaldelyde R add 90 mi of ethanol (96 per cant) Rymnx, add 10 ma. of sulfuric acid R and mix agai. Anise ketone. C,H1,0,.(M, 1642). 1174700, [122-845]. 1-(4 Methosyphenyljpropan'2-one prAnisidine. C,1,NO. (M, 1232). 1203500. [104-848]. 4 Methoxyaniline White or almost white crystals, sparingly soluble in water, soluble im anhydeous ethanol ‘Content: mintenum 97.0 percent. Caution: skin irritant, sensitsr. Storage: protected from light, a 0°C to 4°C. ‘on storage, p-anisdine tends to darken as result of exidation ‘A discoloured reagent can be reduced and decolorced in the fellowing way: dissolve 20g of p-anisidine Rin $00 aL. of water RAt75-°C. Add 1 gof sodium sulfite hepaydrate Rand 10g of activated charcoal R and stir for 3 min. Fier, coal the 2.28) as prescribed in the ‘See the information section on general monograph (over pages}EUROPEAN PHARMACOPOEIA 10.0 4.11, Reagents sate to about 0°C and allow to stand at thie temperature for atleast 4h, Filter, wash the crystals witha small quantity of ‘water Rat about 0°C and dey the crystals in vacuo (2.232), Anthracene. C,H. (M, 1782), 1007400, (120-12-7 White or almost white, crystalline powder, practically insoluble in wate, slightly soluble in chlozotorm, sp: about 218 °C Anthrone. (11,0. (M, 1942). 1007500. (90-44-8] S{10H)-Anthracenone. Pale yellow, mp: about 155 °C. saline powder Antimony potassium tartrate, C\K,0,,5b, 310, (a, 668). 1007600. [28300-74-5}"Dipotassiamn Giltrtrato(4-)0",0%,0",0°}ois{antimonate(D) trihydrate White or almost white, granular powder or colourless, transparent crystals, coluble in water and in pycero,frely soluble in boiling water, practically insoluble in ethanol (66 percent). The aqueots solution is slightly acid Antimony trichloride. SbCL, (M, 228.1). 1007700, fnoo2s-91'9} Colousless crystals of a transparent crystalline mass, hygroscopic, freely soluble ip anhydrous ethanol. Astimony trihloride ts hydrolysed by water. Storage: in an airtight container, protected from moisture Antimony trichloride solution. 1007701 Rapidly wash 30 of antimony trichloride R with two ‘quaniiies, each of 15 ml, af ethanol ree chloroform R, ‘rain olf the washings, and dissolve the washed crystals {immediately in 100 ml. ofethanol-fce chloroform R. warming slightly, Storage: over a fee grams of anhydrous sodium sulfate R Antithrombin 1, 1907800. [90170-80-2]. ‘Antithrombin THis puifed from human plasma by heparin agarose chromatography and should have a speci activity of a least 6 1Uimg, ‘Antithrombin III solution RI, 1007801 Reconaitute antithrombin IH R as direced by the man- facturer and dilute with trisfiydrexymethyDaminomethane sdiuon chloride buffer solution pl1 74 Ro 1 TUimL. Antithrombin III solution R2, 1007802. Reconsitute antithrombin II R as directed by the mans- facturer and dilute with tris{hydrexymethyDaminomethane sodium chloride baer solution pH 7.4 R to 0. TUrmaL, Antithrombin III solution R3, 100780. Reconsitute antithrombin IIR ae directed by the ‘manufacturer and dilute to 03 [U/ml with phosphate buffer solution pl 6.5 8 Antithrombin ITI solution Ra, 1007804 Reconsitute antithrombin IL Ras directed by. the mansfacturer and ddute co 0.1 [Ufa with Inu(hydrosymethyDaminomethane EDTA buffer solution PHAAR Antithrombin III solution RS. 1007805. Reconstitule antithrombin IIR as directed by the manufacturer and dilute to 0.125 TU/aaL with tei(hydroxymethyDaminomethane-EDTA buffer solution pH BARI Antithrombin III colution R6, 100780 Reconsitute antithrombin II R as directed by the manufacturer and dilute to 1.0 1U/m. with IrathydrosymethyDaminomethane EDTA buffer solution pHEARI Apigenin. C110, (M, 2702). 1995800, [520-36-5], 495, Trihydroxyilavane, Light yellowish powder, practically insoluble in water, sparingly soluble in ethanol (96 percent), mp: aboxt 310°C, with decomposition Chromatography. Tin layer chromatography (2.2.27) as prescribed in the monograph Roman chamomile lower (0380) Apply 10 pL of 20.25 g/t. solution in methanol R: the chromatogram shoves inthe upper third a principal zone of yellowish green fuorescence, Apigenin 7-glucoside. 11,0}, (M, 4324), 1095800. {578-745}. Apigetsin. 7-(B-» Glucopyranosyloxy) 5 bydrony-2-(i-hydronyphenyl)-44-1-benzopyran-4-one Light yellowish powder, practically insoluble in seater, sparingly soluble in ethanol (96 percent) mp: 198 °C 10201 °C, ‘Chromatography, ‘Thin layer chromatography (2.2.27) as prescribed in the monograph Roman chamnovsle lower (0380) Spply 10 pL of 20.25 git colution in methanol R; the chromatogram shovre inthe middle third a principal zone of yellowish fluorescence Zpigenin-7-glacosde used in liquid chromatography complies with the following additional tert ‘stay, Liquid chromatography (2.2.29) as presribed inthe ‘monograph Matricara flower (0404) Test solution. Disglve 10.0 mg in methanol R and dilute to 100.0 mL with the same solvent. Content: minimum 950 per cent, calculated by the pormalisation procedure Aprotinin, 1007500. (90 See Aprotinn (0580). Arabinose. C,H10,. (M, 150.1). 1008000. [87-72-9} (GR4S.55) Tetrabydro 21 pyran 23.4.5-tetrl 1-Arabinopyranose,{-(+)-Arabinose, White or almost whit, crystalline powder, freely soluble in 4, Reagent 0.1 af: + 103 to + 105, determined on a 50 git. solution in ‘ater R containing about 0.05 per cent of NH, Arachidyl alcohol. Cy!1,0.(M, 298.5). 1156300. (628-96-8] 1-Bicosanal mp: about 65 °C Content: minimum 96 per ce Arbutin, C,.11,0,. (M, 272.3), 1008100. [487-767] ‘Arbutoside. & HydroxyphenyB-0-glucopyranoside Fine, white or almost white, shiny needles, freely soluble in water very soluble in hot wate, soluble in ethanol (96 per cent) ‘Chromatography, Thin-layer chromatography (2.227) as prescribed inthe monograph Bsarberry leaf (1054); the ‘chromatogram shows only one principal spot Arginine, 1103800. [7479-3]. See Arginine (0808) Argon. Ax. (A, 39.95). 1008200, (7440:37-1] ‘Content, minimum 99.995 per cent V/V. Carbon monoxide (2.5.25, Method I: maximum 0 ppm V/V: ler pasrage of 10 Lof argon Rata low rate of 4 Li, not ‘more than 0.05 ml. of 0.002 M sodium thiosulfate erequited 6 uration. ‘Argon RI. Ac (4, 3995). 1176000. [7440-37-1 Content: minimum 99.99990 per cent V/V, 11,0. ‘Argon for chromatography. Ar (A, 39.95), 1165200, irito-37-1]. Content: minimum 99.95 per eent V/V. ‘General Notices (0) apply to all monographs and other texts waALA. Reagents EUROPEAN PHARMACOPOEIA 100 Aromadendrene. Cyl. (M,2044). 1138100. [489-38-4] (RAS ARARIR)-33,11 Trimethyl-7-methylenetricyclo. [63.0.0 Jjundecane Clear, almost colourless liquid 42 about 0.911 ni sshout 1457 (ef: about +12. bp: about 263 °C Avomadendrene used in gas chromatography complies with the following adaitiona test, “Arsay. Gas chromatography (2.228) as prescribed in the monograph on Tea tee oi (1837). Content: minimum 92 per cent, ealeulated by the normalisation procedure Arsenazo IT. C,,A8,N,0,S5 (M, 776). 1198200 {1668-00-4). 3,6-Bisf(2arsonopheny) diazenyl]-45- (ihydronynaphithalene-2,7-dislfonic acid Brown powder. Arsenious trioxide. As,0,.(M, 197.8), 1008300, 327-53-3] ‘Arsenious anhydride, Diarsenic oxide Crystalline poseder ors white or almost white mass, sighlly sll in wate, soluble in boiling wate, Ascorbic acid. 1008400, [50-81-7] See Ascorbic aid (0253). Ascorbic acid solution, 1008401 Dissolve 50 mg in 0.5 ml. of water R and dilute to 50 ml with dimethylformamide R Asiaticoside. C,H.,0,, (M, 959), 1123500. [18830-15.2]. 05 Beexy a-L-mannopyranosyl Go4)-0 B.D glucopyranosyl (196) 3-0-glacopyran 24,38,23-tihydroxy aur 12-en-28-oat White or almost white powder, hygroscopic, sluble in smthanal, slightly soluble ip anhydrous ethanol insoluble in acetonitrile, mp! about 282 °C, with decomposition Water (25.12): 60 per cen Asaticoside wed in liquid chromatography complies with the following additional tes. “Assay. Ligaid chromatography (2229) as prescribed in the mnograph Centella (1498) Content: minimum 97.0 per cent, ealeulated by the normalisation procedure, Storage: protected from humidity, sy Asparagine. C,HN,O, (M, 182.12), 1200000, (70-47-3] Aspartic acid, 1134100, [56 84 8] See Aspartic acid (0797), -Aspartic acid, C,H,NO, (M, 1331), 1200100, 1783:96-6) 1-Aspartyl-t-phenylalanine. C,,1,N,O, (M, 2803) 4008500. [13483-09-5),(S)-3-Atning-N-{{S)-1-carboxy-2: phenylethyl-succinamic acid, White or almost white powder. about 210°C, with decomposition Astragaloside IV. C,H, (3,785). 1178200. {84687-43-4]. (208 245}20134-Bpoxy-168,25-dibydroxy 38:8. -xylopyranosyloxy)-9,19-cydolanostan-6a yl Bro elucepyranoside Atropine sulfate. 1153000. [5908-996] See Atropine sulfate (0068) Aucubin. CHO, (M, 346.3). 1145200. [479-98-1 [154k 55,785) 5 iydrory-7 (hydroxymethyl) -1,4,5,79 tetralydeocyclopentalelpyran-L-yl p-b-glucopyranoside. (Crystals, soluble in water, in ethanol (96 per cent) and in ‘methanol, practically insoluble in light petroleum. {os about ~ 153 sp: about 181 °C Azomethine H. C,H, NNaO,S,. (M, 445.4. 1008700 [5941-07-1], Sodisim hydrogeno-4-hydroxy-5-(2 hydroxybenzylideneamina)-2,7-naphthalenedisulfonate ‘Azomethine H tolution. 1008701 Diseolve 0.45 g of azomethine 11 and lg of ascorbic aid R ‘with gentle healing in water Rand dilote o 100 mt. with the same solvent, Baicalin. C,H,0,. (M, 446.4). 1179200, [21967-41-9} 5,6-Dibydroxy-4-oxo-2-phenyl-4H-1-benzopyran-7-1-6-D- lucopyranosiduronie acid, Barbaloin. C,H,,0,H,0. (M, 4864), 1008800, (1415-73-2). Alain. 118 -Dibydtoxy-3-hydroxymethyl-10-B-0- elscopyranoeyl-OH-antbracen-9-one. Yello to darkyellow, crystallin povede, or yellow needles, darkening on exposure to ait and light, sparingly soluble in. ‘water and in ethanol (96 per cent, soluble in acetone, in fmmonia and in solution of alkali hydroxides. AT about 192 a 269 nm, about 226 a 296.5 nm, about 259 354 am, determined on a solution in methanol Rand ‘aleuated with reference lo the anhydrous substance. ‘Chromatography, Thin-layer chromatography (2.227) as prescribed i the monogeaph Frangula bark (0025); the ‘chromatogram shove only one principal spot Barbital, 1008900. (57-443 See Barbital (0170) Barbital sodium. C,H,.N:N2O,, (M, 2062). 1008000. (144-02-5). Sodium derivative of 5.5-diethyl-1H,3115H. pyrimidine-2,4,6-rione Content: minimum 98.0 per eent A white or almost white crystalline powder or colourless crystals, freely soluble in water, slighty soluble in ethanol (86 per cent) Barbituric acid. H,N,0,,(M, 128.1), 1009100, [67-52-7) IN3HSHE Pyrimidine-2,4,5-tione. White or almost white poveder, slighty soluble in water, frely soluble in boiling water and in dilute ac mp: about 253 Barium acetate. C}H,Ba0,. (M, 2554), 1162700, Barium diacetate White or almost white powder, soluble in water aR: ar Barium carbonate. BaCO,, (3, 197.3). 1009200. (513-77-5]. White or almost white power or friable masses, practical insoluble in water Barium chloride, BaCl,2H1,0. (0, 2443). 1009300, [10326-27-8]. Barium dichloride Colousless crystals, feey salable in water, slighty soloble in cthanal (96 per cen), Barium chloride solution R1. 1009301 A641 gil solution of barium chloride B. Barium chloride solution R2, 1009302, A 365 gil. solution of barium chloride R ‘See the information section on general monograph (over pages}