Pharmaceutical Quality Management-I (614-T)
Lecture by;
Prof. Dr. Amber Nawab
Chairperson(Pharmaceutics)
Faculty of Pharmacy
Jinnah University for Women.
Objective of today’s lecture
• Elixir
• Quality Control Tests for Elixir
Elixers
Elixirs are clear ,sweetened hydroalcoholic s
olutions intended for oral use and are
usually flavored to enhance their palatability.
Types of Elixir:
• On the bases of medicinal agent;
1. Medicated elixir
2. Non medicated elixir
• On the bases of alcoholic content;
1. High alcoholic elixir
2. High alcoholic elixir
• NON MEDICATED ELISXIRS:
Simple , no therapeutic agents.
may only have alcohol , sweetening agent ,
coloring agent.
Self preservative, if contained more than 12%
alcohol.
• USES:
• They are used only as diluting agents, Preservative,
flavoring agent or additives for other preparations
• EXAMPLES:
• Aromatic Elixir , Iso-alcoholic Elixir
• MEDICATED ELIXIRS:
Medicated elixirs are solution of active constituent
s liquefied in water and alcohol. Provides therapeu
tic action in a palatable form. Since elixirs are true
solution, this reflects that they delivers the active
drug to the blood stream rapidly and efficiently.
EXAMPLE OF MEDICATED ELIXIR:
1. Diphen hydramine elixirs (Antihistamine).
2. Terpen hydrate elixir (Expectorant).
3. Phenobarbital elixirs (sedative and hypnotic)
4. Chloral hydrate elixir (sedative and hypnotics).
• HIGH ALCOHOLIC ELIXIR:
75-78% alcohol
• LOW ALCOHOLIC ELIXIR:
8-10% alcohol
• Note: elixir containing at least 10-12%
alcohol is already self preserving.
Quality Control Tests for Elixers
1. Visual inspection
2. pH measurement
3. Refractive Index
4. Viscosity
5. Determination of Alcohol content
6. Weight/ml
7. Assay
1. Visual Inspection
Elixir should be:
• Clear and Good looking
• Elegant in appearance
• Color and odor should be pleasant
Physical appearance is important for patient
adherence and compliance
2. pH Measurement
• The measurement and maintenance of pH is also
very important step in the Quality control testing.
• pH of the oral liquid preparations must be optimu
m as they are administered. The pH value convent
ionally represents the acidity or alkalinity of an aq
ueous solution.
• Generally, pH range should be between 6-7
Methods for pH measurement:
i. pH paper: The simplest & cheapest method is
to dip a piece of pH paper into the sample. The
sample is impregnated with chemicals that change
the color lamp; color may be compare to a chart
supplied with the paper to give the pH of the sa
mple.
Methods for pH measurement:
ii. pH meter: The determination is carried out at a temper
ature of 25±2°C, unless otherwise specified in the
individual monograph. The pH value of a solution is deter
mined potentiometrically by means of a glass electrode,
a reference electrode and a pH meter either of the digital
or analogue type.
3. Refractive Index
• It is measured by refractometer.
• It should be between 1.4608- 1.4630.
• It is measured by using refractrometer
4. Viscosity
• Viscosity is a property of liquids that is
directly related to the resistance to flow.
• Viscosity measurement is very important
quality control test in case of syrups an elixirs.
• Viscosity and consistency directly relates
with stability of solutions.
• The greater the viscosity, the greater the stab
ility.
Methods For Viscosity Measurement
– U tube viscometer
– Capillary viscometer method
– Rotating viscometer
– Concentric cylinder viscometers
– Cone- plate viscometers
– Spindle viscometers
5. Determination of Alcohol Concentration
• Elixir usually contains 5 -40% alcohol.
• The determination of alcohol unless otherwise specified in
the individual monograph. It is suitable for examining
most fluid extract, tinctures & elixirs provided the capacit
y of distillating flask is sufficient (size of distillating flask
should be 3-4times larger than the volume of sample used)
and the rate of distillation is such that clear distillates are
produced.
• Cloudy distillates may be clarified by agitation with talc
or with calcium carbonate & filtration is done.
• After which the temperature of filtrate is adjusted and; the
alcohol content is determined from the specific gravity .
• Using the result ,ascertain the % of alcohol by
Alcoholometric table.
• During all manipulation, take precaution to minimize the
loss of alcohol by evaporation .
Alcoholometric table
6. Weight/ml
• The weight per millilitre (weight per mL) of a
liquid is the weight in g of 1 mL of a liquid wh
en weighed in air at 20°C, unless
otherwise specified in the monograph.
METHOD:
• It is determined by: = weight in air (g)/ Weight
of liquid that fill the pycnometer(ml) .
• Capacity of pycnometer is determined from wt
. in air (g), of the quantity of water required to
fill pycnometer at that temp.
Density
• Density (P20) is determined by dividing the wt. in air of th
e quantity of liquid being examined that fills
pycnometer at 20 degree by weight in air of water required
filling the pycnometer after making allowance
for the thrust of air.
• P20 = 998.2 (M1 + A) /M2 + A
• M1= apparent mass (g) of sample, M2= apparent mass
(g) of water, A = correction factor for thrust of air,
0.0012M2
998.2= density of water at 20° in kg.m-3.
Thrust is the force which moves water through the air.
7.Assay
Assay and test procedures are used to determi
ne compliance with the pharmacopeial standa
rds of identity, strength, quality, and purity.
Chromatographic methods are commonly use
d for detection and quantitation
Summary
• Quality Control Tests of Syrup
7. Viscosity
8. Solubility
9. Optical Rotation
10. Assay
11. Weight/ml (Density)
12. Refractive Index
• Elixir
• Quality Control Tests for Elixir
References
• Ansel’s pharmaceutical dosage forms and drug deliver
y systems (2011). 9th ed. Philadelphia, PA: Lippincott
Williams & Wilkins
• Lachman, Leon; Lieberman, Herbert A.; Kanig, Josep
h L.,eds. The theory and practice of industrial pharma
cy. 3rd ed.Philadelphia, PA: Lea &Febiger, 1986
• Remington: The Science and Practice of Pharmacy
