STUDY NUMBER: GALA-3685-20

ANALYTE NAME: GALANTAMINE

EXPERIMENT: SYSTEM SUITABILITY
DATE : 23-Sep-20

RETENTION TIME
AREA
S.No. INTERNAL
ANALYTE RATIO
STANDARD
1 1.755 1.755 1609359.875
2 1.756 1.756 1708204.625
3 1.755 1.755 1763250
4 1.762 1.755 1790583.5
5 1.762 1.755 1826838.25
6 1.762 1.755 1818148.625
MEAN 1.75867 1.75517 1752730.81250
STD DEV. 0.003670 0.000408 82283.277566
% CV 0.21 0.02 4.69
Result PASS PASS PASS

Criteria
% CV of area ratio should be less than or equal to 5%
% CV of analyte and IS retention time should be less than or equal to 15%

Prepared by Checked by
 PROJECT NUMBER: MV-474-20
ANALYTE NAME: Galantamine
EXPERIMENT: Specificity & Selectivity
DATE : 18-Sep-20

TOTAL No. OF LOTS 9 No. OF PASSING LOTS

Plasma Specificity Selectivity

Lot ID (Blank) ( Spiked LLOQ)
Analyte IS peak Analyte IS peak
Blank-MAT-0532-II 0 0 7212 64935
Blank-MAT-0533-II 0 0 7065 63501
Blank-MAT-0534-II 0 0 7847 72360
Blank-MAT-0535-II 0 7 8238 76411
Blank-MAT-0536-II 0 0 8480 79783
Blank-MAT-0537-II 0 0 7689 72173
Blank-MAT-0475-III (Heparin) 0 6 7042 62712
Blank-MAT-0515-II (Hemolysed) 0 2 7699 69747
Blank-MAT-0510-II (Lipemic) 0 0 7575 71437
Mean

% of Lots passing = 100.00 %

ACCEPTANCE CRITERIA:

i) Responses of the interfering peak in blank at the retention time of the Analyte and or metabolite should be <20% of the responses of the respective LLOQ sample.
ii) Responses of the interfering peak in blank at the retention time of the internal standard should be <5% of the average responses of the internal standard observed in the
iii) %CV of the area ratio (analyte/IS) in the extracted LLOQ samples should be ≤20.
iv) S/N ratio of each LLOQ samples should be ≥ 5.
v) Ensure that 100% matrix lots including, lipemic, hemolysed and heparin lots should meet the requirement.

Prepared by
 20
mine
ty & Selectivity
0

No. OF PASSING LOTS 9

% Interference S/N Ratio

Area Ratio
in Blank (≥5)
Analyte Analyte/IS
IS(<5%) Analyte
(<20%)
0.0000 0.0000 0.1111
0.0000 0.0000 0.1113
0.0000 0.0000 0.1085
0.0000 0.0092 0.1078
0.0000 0.0000 0.1063
0.0000 0.0000 0.1065
0.0000 0.0096 0.1123
0.0000 0.0029 0.1104
0.0000 0.0000 0.106
0.00000 0.00240 0.10891
SD 0.002416
%CV 2.22
Result Pass

the responses of the respective LLOQ sample.

ge responses of the internal standard observed in the sample of LLOQ run along with the batch.

Checked by
 STUDY NUMBER:
ANALYTE NAME:
EXPERIMENT: Selectivity in presence of OTC drugs
DATE :

TOTAL No. OF LOTS No. OF PASSING LOTS

Plasma Specificity Selectivity % Interference

Lot ID (Blank) ( Spiked LLOQ) in Blank
Analyte
Analyte IS peak Analyte IS peak IS(<5%)
(<20%)

Mean
SD
% of Lots passing = % %CV
Result
ACCEPTANCE CRITERIA:

.i) Responses of the interfering peak in blank at the retention time of the Analyte and or metabolite should be <20% of the responses of the respective LLOQ sample.
ii) Responses of the interfering peak in blank at the retention time of the internal standard should be <5% of the responses of the internal standard observed in the sample
with the batch.
iii) %CV of the area ratio (analyte/IS) in the extracted LLOQ samples should be ≤20.
iv) S/N ratio of each LLOQ samples should be ≥ 5.

Prepared by Checked by
 S/N Ratio
Area Ratio
(≥5)
Analyte/IS
Analyte

ses of the respective LLOQ sample.

nternal standard observed in the sample of LLOQ run along
 STUDY NUMBER:
ANALYTE NAME:
EXPERIMENT: Matrix Screening
DATE :

TOTAL No. OF LOTS No. OF PASSING LOTS

Plasma Specificity Selectivity % Interference

Lot ID (Blank) ( Spiked LLOQ) in Blank
Analyte
Analyte IS peak Analyte IS peak
(<20%)
89954 788924 0.0000
88627 785225 0.0000
88738 798784 0.0000
88120 793294 0.0000
86586 791471 0.0000
88074 844014 0.0000
87579 841443 0.0000
86037 802608 0.0000
89837 819361 0.0000
86395 796987 0.0000

Mean 0.00000

% of Lots passing = %

ACCEPTANCE CRITERIA:

i) Responses of the interfering peak in blank at the retention time of the Analyte and or metabolite should be <20% of the responses of the respective LLOQ sample.
ii) Responses of the interfering peak in blank at the retention time of the internal standard should be <5% of the responses of the internal standard observed in the sample
batch.
iii) %CV of the area ratio (analyte/IS) in the extracted LLOQ samples should be ≤20.
iv) S/N ratio of each LLOQ samples should be ≥ 5.
v) Ensure atleast 80% of the matrix lots should meet the requirement.
Prepared by Checked by
 % Interference S/N Ratio
Area Ratio
in Blank (≥5)
Analyte/IS
IS(<5%) Analyte
0.0000 0.1140
0.0000 0.1129
0.0000 0.1111
0.0000 0.1111
0.0000 0.1094
0.0000 0.1044
0.0000 0.1041
0.0000 0.1072
0.0000 0.1096
0.0000 0.1084

0.00000 0.10922
SD 0.003297
%CV 3.02
Result Pass

esponses of the respective LLOQ sample.

f the internal standard observed in the sample of LLOQ run along with the
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: MATRIX EFFECT
DATE :

Standard Units A B C
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LQC-01 LQC-02

Actual
Concentration
(µg/mL)

Mean
SD
%CV
%Nominal

LQC LQC
%CV Criteria
%NOMINAL Criteria

Prepared by
 D E F G H SLOPE INTERCEPT

LQC-03 HQC-01 HQC-02 HQC-03

LQC HQC HQC HQC

Checked by
r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: MATRIX EFFECT
DATE :

A B C
Standard Units
Actual (ng/mL)
Concentration
Calculated (ng/mL)
Concentration

%Nominal

Result

QC ID LQC-01 LQC-02

Actual Concentration
(ng/mL)

Mean
SD
%CV
%Nominal

LQC LQC
%CV Criteria
%NOMINAL Criteria

Prepared by
 D E F G H I
SLOPE

LQC-03 HQC-01 HQC-02 HQC-03

LQC HQC HQC HQC

Checked by
 r2
INTERCEPT
 MV NUMBER: MV-474-20
ANALYTE NAME: Galantamine
EXPERIMENT: IS NORMALIZED MATRIX FACTOR-LQC
DATE : 18-Sep-20

Aqueous Sample Spiked Sample Matrix Factor Area Ratio

Limit for IS
Lot No. Spiked
Analyte Area IS Area Analyte Area IS Area Analyte IS IS Normalized Aqueous Sample Normalized MF
Sample
LQC-MAT-0532-II 20170 71579 20950 77647 1.03 1.05 0.98 0.2818 0.2698 Pass
LQC-MAT-0533-II 18868 67151 19706 72346 0.97 0.98 0.99 0.281 0.2724 Pass
LQC-MAT-0534-II 19564 70545 21132 77234 1.04 1.05 0.99 0.2773 0.2736 Pass
LQC-MAT-0535-II 20761 76056 21766 79058 1.07 1.07 1.00 0.273 0.2753 Pass
LQC-MAT-0536-II 21345 77931 21779 81426 1.07 1.10 0.97 0.2739 0.2675 Pass
LQC-MAT-0537-II 21285 79542 22405 83271 1.10 1.13 0.97 0.2676 0.2691 Pass
LQC-MAT-0475-III (Heparin) 22025 82347 1.08 1.12 0.96 0.2675 Pass
LQC-MAT-0515-II (Hemolysed) 21196 78274 1.04 1.06 0.98 0.2708 Pass
LQC-MAT-0510-II (Lipemic) 21881 81258 1.08 1.10 0.98 0.2693 Pass
Mean 20332.16667 73800.66667 MEAN 0.98000 0.27577 0.27059
SD 0.012247
%CV 1.25
LIMIT Pass
MINIMUM 0.96
MAXIMUM 1.00

ACCEPTANCE CRITERIA:
MATRIX FACTOR SHOULD BE WITHIN 0.85 TO 1.15.
% CV OF MATRIX FACTOR SHOULD BE ≤ 15%;
N/AP : Not Applicable

Prepared by Checked by
 MV NUMBER: MV-474-20
ANALYTE NAME: Galantamine
EXPERIMENT: IS NORMALIZED MATRIX FACTOR-HQC
DATE : 18-Sep-20

Aqueous Sample Spiked Sample Matrix Factor Area Ratio

Limit for IS
Lot No. Spiked
Analyte Area IS Area Analyte Area IS Area Analyte IS IS Normalized Aqueous Sample Normalized MF
Sample
HQC-MAT-0532-II 1691028 90199 1712216 90806 1.01 1.01 1.00 18.7478 18.8558 Pass
HQC-MAT-0533-II 1728428 91340 1705614 91527 1.00 1.02 0.98 18.923 18.6351 Pass
HQC-MAT-0534-II 1750462 92097 1716404 92229 1.01 1.03 0.98 19.0067 18.6102 Pass
HQC-MAT-0535-II 1737580 92508 1747753 94072 1.03 1.05 0.98 18.783 18.5789 Pass
HQC-MAT-0536-II 1678667 87426 1774514 95284 1.04 1.06 0.98 19.201 18.6234 Pass
HQC-MAT-0537-II 1623834 84539 1675378 89256 0.98 1.00 0.98 19.2081 18.7705 Pass
HQC-MAT-0475-III (Heparin) 1723107 90242 1.01 1.01 1.00 19.0942 Pass
HQC-MAT-0515-II (Hemolysed) 1774567 93153 1.04 1.04 1.00 19.0499 Pass
HQC-MAT-0510-II (Lipemic) 1802839 94862 1.06 1.06 1.00 19.0049 Pass
Mean 1701666.50000 89684.83333 MEAN 0.98889 18.97827 18.80254
SD 0.010541
%CV 1.07
LIMIT Pass
MINIMUM 0.98
MAXIMUM 1.00

ACCEPTANCE CRITERIA:
MATRIX FACTOR SHOULD BE WITHIN 0.85 TO 1.15.
% CV OF MATRIX FACTOR SHOULD BE ≤ 15%;
N/AP : Not Applicable

Prepared by Checked by
 MV NUMBER: MV-474-20
ANALYTE NAME: Galantamine
EXPERIMENT: CARRY OVER TEST
DATE : 18-Sep-20

Sample ID Analyte peak area IS peak area

Extracted blank 0 5
Extracted LLOQ+IS 12576 103340
Extracted ULOQ+IS 2454223 117713
Extracted blank-I 0 6
Extracted blank-II 156 8
% Carry Over from Blank I 0.00 0.00

% Carry Over from Blank II 1.24 0.00

Result for blank - I Pass Pass
Result for blank - II Pass Pass

ACCEPTANCE CRITERIA: FOR ANALYTE % CARRY OVER <20 OF LLOQ area.

FOR IS % CARRY OVER < 5 FOR IS AREA

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WEIGHTING FACTOR
DATE :

WEIGHTING FACTOR WEIGHTING FACTOR WEIGHTING FACTOR

None 1/X 1/X2
Absolute Absolute Absolute
Observed Observed Observed
Relative Relative Relative
Value Value Value
Error Error Error

SUM 0.00 SUM 0.00 SUM 0.00

Prepared by Checked by
 STUDY NUMBER:
ANALYTE NAME:
EXPERIMENT: WEIGHTING FACTOR
DATE :

ACCURACY ABSOLUTE ACCURACY ABSOLUTE ACCURACY ABSOLUTE

(%) RESIDUAL (%) RESIDUAL (%) RESIDUAL
1/X2 1/X NONE

SUM 0.00 0.00 0.00

Prepared by Checked by
PROJECT NUMBER:

ANALYTE NAME:

EXPERIMENT:

DATE :

ACCURACY ABSOLUTE ACCURACY ABSOLUTE

(%) RESIDUAL (%) RESIDUAL
1/X2 1/X

SUM 0.00 0.00

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT STANDARD RANGE TEST
DATE

Points Concentration (ng/mL)

1
2
3
4
5
6
7
8

1. For Lowest Concentration

Step 1: Arrange value in increasing order (as per table)

Step 2: Range=Highest concentration-Lowest concentration

Range=

Step 3: Module=D=Difference between two lowest value

D=

Step 4: Ratio=Q=D/Range

Ratio Q=

Step 5: Q 95% at n (=8) = 0.52

Q < Q95% so <STD A conc.> is acceptable value

2. For Highest Concentration

Step 1: Arrange value in increasing order (as per table)

Step 2: Range=Highest concentration-Lowest concentration

Range=

Step 3: Module=D2=Difference between two highest value

D2=

Step 4: Ratio=Q2=D2/Range

Ratio Q2=

Step 5: Q 95% at n (=8) = 0.52

Q2 < Q95% so <STD H conc.> is acceptable value

Prepared by: Checked By:

 MV NUMBER: MV-308-14-
ANALYTE NAME: LOPERAMIDE
EXPERIMENT: P&A BATCH - TRIAL P & A
DATE :
Standard Units SLOPE INTERCEPT
Actual
A B C D E F G H r2
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 STUDY NUMBER:
ANALYTE NAME:
EXPERIMENT:
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - TRIAL P & A - 02
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - TRIAL P & A - 03
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)
 Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A-01
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria
 Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A-02
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A-03
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 04
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)
 Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A-05
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 06
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC

%CV Criteria
%NOMINAL Criteria

Prepared by

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - GLOBAL (Inter batch Accuracy and Pre
DATE :

A B C D E
Actual
Concentration
(ng/mL)
P & A 01
P & A 02
P & A 03
P & A 04
P & A 05
P & A 06
 P & A 07
P & A 08
P & A 09
P & A 10
Mean
Std
%CV
%Nominal

BETWEEN
BATCH
QC ID LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)
P&A -1

P&A -2

P&A -3

P&A -4

P&A -5

P&A -6

P&A -7
 P&A -8

P&A -9

P&A -10

Mean
SD
%CV
%Nominal

MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - Intra batch Accuracy and Precision
DATE :

P&A1 LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A2 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)
 Mean
SD
%CV
%Nominal
P&A3 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A4 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A5 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A6 LOQQC LQC INTQC MQC HQC
 Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A7 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A8 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A9 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
 %CV
%Nominal
P & A 10 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
 E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

Checked by

A - 02

E F G H SLOPE INTERCEPT r2
 MQC HQC DQC

MQC HQC DQC

Checked by

A - 03

E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

Checked by

E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

 Checked by

E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

Checked by

E F G H SLOPE INTERCEPT r2
MQC HQC DQC

MQC HQC DQC

Checked by

E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

Checked by

E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

Checked by
 E F G H SLOPE INTERCEPT r2

MQC HQC DQC

MQC HQC DQC

Checked by

AL (Inter batch Accuracy and Precision)

F G H SLOPE INTERCEPT r2
DQC
 LOQQC LQC, INTQC, MQC, HQC and DQC
%CV Criteria
Minimum 0.00 0.00
Maximum 0.00 0.00
%NOMINAL Criteria
Minimum 0.00 0.00
Maximum 0.00 0.00

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Accuracy and Precision

DQC

DQC
DQC

LOQQC
LQC, INTQC, MQC and HQC
%CV Criteria
Minimum 0.00 0.00
Maximum 0.00 0.00
%NOMINAL Criteria
Minimum 0.00 0.00
DQC Maximum 0.00 0.00

DQC

HQC
DQC

DQC

DQC
DQC
DQC
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT:
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - TRIAL P & A - 02
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - TRIAL P & A - 03
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 01
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 02
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 03
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 04
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 05
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 06
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 07
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 08
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 09
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - P & A - 10
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LOQQC LQC INTQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: P&A BATCH - GLOBAL (Inter batch Accuracy and Precision)
DATE :

A B C D E F G H I SLOPE INTERCEPT r2
Actual
Concentration
(ng/mL)
P & A 01
P & A 02
P & A 03
P & A 04
P & A 05
P & A 06
P & A 07
P & A 08
P & A 09
P & A 10
Mean
Std
%CV
%Nominal

BETWEEN
BATCH
QC ID LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)
P&A -1

P&A -2

P&A -3
P&A -4

P&A -5

P&A -6

P&A -7

P&A -8

P&A -9

P&A -10
 Mean LOQQC LQC INTQC MQC HQC
SD %CV Criteria
%CV %NOMINAL Criteria
%Nominal
 PROJECT NUMBER:
METABOLITE NAME:
EXPERIMENT: P&A BATCH - Intra batch Accuracy and Precision
DATE :

P&A1 LOQQC LQC INTQC MQC HQC

Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A2 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A3 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

LOQQC LQC, INTQC, MQC and HQC

%CV Criteria
Mean Minimum 0.00 0.00
SD Maximum 0.00 0.00
 %CV %NOMINAL Criteria
%Nominal Minimum 0.00 0.00
P&A4 LOQQC LQC INTQC MQC HQC Maximum 0.00 0.00
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A5 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A6 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A7 LOQQC LQC INTQC MQC HQC
 Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A8 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P&A9 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal
P & A 10 LOQQC LQC INTQC MQC HQC
Actual
Concentration
(ng/mL)
 Mean
SD
%CV
%Nominal
r2
r2
r2
r2
r2
r2
r2
r2
r2
r2
r2
r2
r2
MV NUMBER:
LYTE NAME:
XPERIMENT:
DATE :

Units A B C D E F G H SLOPE INTERCEPT r2

(ng/mL)

(ng/mL)

inal

QC ID LQC MQC HQC

Actual Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT:
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual (ng/mL)
Concentration
Calculated (ng/mL)
Concentration
%Nominal
Result

QC ID LQC MQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
%Nominal

LQC MQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER: MV-474-20
ANALYTE NAME: Galantamine
EXPERIMENT: ANALYTE RECOVERY
DATE :

Quality Control Aqueous Extracted

Samples ID Analyte Area Analyte Area
23374
22548
LQC 21153
20611
20988
21226
Mean 21650
SD 1070
%CV 4.94
Result Pass
% Recovery
903469
936394
MQC 940388
928114
893355
870462
Mean 912030
SD 27591
%CV 3.03
Result Pass
% Recovery
1763021
1923342
HQC 2043882
2089743
2068029
2002542
Mean 1981760
SD 122191
%CV 6.17
Result Pass
% Recovery

Recovery Result Difference between % Recovery

LQC LQC & MQC
MQC Result
HQC LQC & HQC
Result Result
MEAN MQC & HQC
SD Result
%CV
Result

ACCEPTANCE CRITERIA:
i) PERCENT RECOVERY FOR ANALYTE OR IS SHOULD NOT BE MORE THAN 110%
ii) %CV OF THE MEAN RECOVERY OF THE LOW, MEDIUM, HIGH QC
SAMPLES TOGETHER SHOULD BE ≤15%
iii) %CV OF THE INDIVIDUAL QC'S AT EACH LEVEL (LQC, MQC & HQC) SHOULD BE ≤15%
iv) DIFFERENCE OF %RECOVERY BETWEEN ANY OF TWO INDIVIDUAL QCs SHOULD BE ≤15%

Prepared by Checked by
 MV NUMBER: MV-474-20
ANALYTE NAME: Galantamine
EXPERIMENT: INTERNAL STANDARD RECOVERY
DATE :

Quality Control Aqueous Extracted

Samples ID IS Area IS Area
23374
22548
LQC 21153
20611
20988
21226
105689
110922
MQC 110540
110482
103905
100459
101916
114983
HQC 123277
126266
123229
120044
Mean 82311.77780
% Recovery
Result

ACCEPTANCE CRITERIA:

i) PERCENT RECOVERY FOR ANALYTE OR IS SHOULD NOT BE MORE THAN 110%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: Reinjection Reproducibility
DATE :

Batch ID Reinjection Reproducibility

PA-XX Reinjected Samples XX.XX (Hours)
LQC HQC LQC HQC
Actual Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
% Nominal
LIMIT
Ratio of Means
LIMIT

ACCEPTANCE CRITERIA:
i) The mean of back calculated valus should be between 85 to 115% of the nominal concentration
ii) % CV should be ≤15%.
iii) Ratio of means should be within 0.85 to 1.15 while comparing the mean of back-calculated values against the mean of values obtained from an
original injection.
Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: STABILITY OF DRUG/METABOLITES IN BLOOD
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

Result

0 Hour
LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(ng/mL)
ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%

Calculated The accuracy for stability sample against comparison sample is within ± 15%
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: STABILITY OF DRUG/METABOLITES IN BLOOD
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

Result

0 Hour
LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(ng/mL)
ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%

Calculated The accuracy for stability sample against comparison sample

Concentrations is within ± 15%
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: HAEMOLYTIC EFFECT
DATE :

Standard Units A B C D
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LQC HQC

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal

Prepared by
CT

E F G H I SLOPE INTERCEPT r2

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%

Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: HAEMOLYTIC EFFECT
DATE :

Standard Units A B C D E
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LQC HQC

Actual
Concentration
(ng/mL)
ACCEPTANCE CRITERIA:
The accuracy for stability sample is with
and the precision is ≤ 15%

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal

Prepared by
 F G H SLOPE INTERCEPT r2

CCEPTANCE CRITERIA:
e accuracy for stability sample is within ± 15%
d the precision is ≤ 15%
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WORKING SOLUTION STABILITY - LQC
DATE :

FOR ANALYTE
Solution 1 (XX.XX Hours) Solution 3 (0 HOURS)
S. No. Analyte Area IS Area Area Ratio S.NO Analyte Area IS Area Area Ratio
1 69510 318928 0.2179 1 49319 271814 0.1814
2 65717 322972 0.2035 2 52287 289036 0.1809
3 65998 346906 0.1902 3 57103 319289 0.1788
4 69455 366914 0.1893 4 57985 318847 0.1819
5 58034 307878 0.1885 5 58043 320888 0.1809
6 51417 269263 0.1910 6 49669 272680 0.1822
Mean 0.19673 Mean 0.18102
Stability of the Working Solution = 108.68 %
Result Pass %

FOR INTERNAL STANDARD

Solution 2 (XX.XX Hours) Solution 3 (0 HOURS)
S. No. Analyte Area IS Area Area Ratio S.NO Analyte Area IS Area Area Ratio
1 55939 308011 5.5062 1 49319 271814 5.5113
2 56267 307372 5.4627 2 52287 289036 5.5279
3 53047 287448 5.4187 3 57103 319289 5.5915
4 47548 255901 5.3820 4 57985 318847 5.4988
5 49487 267867 5.4129 5 58043 320888 5.5285
6 58809 322783 5.4887 6 49669 272680 5.4899
Mean 5.44519 Mean 5.52464
Stability of the Working Solution = 98.56 %
Result Pass %

ACCEPTANCE CRITERIA: The mean area ratio of the working stock solution (room temperature) of analyte or IS
versus the refriegerated working solution is within the range of 90 to 110%.

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WORKING SOLUTION STABILITY - HQC
DATE :

FOR ANALYTE
Solution 1 (XX.XX Hours) Solution 3 (0 HOURS)
S. No. Analyte Area IS Area Area Ratio S.NO Analyte Area IS Area Area Ratio
1 1446596 230293 6.2815 1 1779390 294547 6.0411
2 1548585 252729 6.1274 2 2041974 336684 6.0650
3 1622598 269093 6.0299 3 1737398 282764 6.1443
4 1660624 275490 6.0279 4 1629930 262497 6.2093
5 1781019 294834 6.0407 5 1816198 294809 6.1606
6 1932177 319295 6.0514 6 2068560 339463 6.0936
Mean 6.09313 Mean 6.11898
Stability of the Working Solution = 99.58 %
Result Pass %

FOR INTERNAL STANDARD

Solution 2 (XX.XX Hours) Solution 3 (0 HOURS)
S. No. Analyte Area IS Area Area Ratio S.NO Analyte Area IS Area Area Ratio
1 2041678 335526 0.1643 1 1779390 294547 0.1655
2 1834496 294701 0.1606 2 2041974 336684 0.1649
3 1943653 314018 0.1616 3 1737398 282764 0.1628
4 2349519 387407 0.1649 4 1629930 262497 0.1610
5 2291644 378986 0.1654 5 1816198 294809 0.1623
6 2533442 418286 0.1651 6 2068560 339463 0.1641
Mean 0.16365 Mean 0.16344
Stability of the Working Solution = 100.13 %
Result Pass %

ACCEPTANCE CRITERIA: The mean area ratio of the working stock solution (room temperature) of analyte or IS
versus the refriegerated working solution is within the range of 90 to 110%.
Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: SHORT TERM STOCK STABILITY - LQC
DATE :

FOR ANALYTE
Solution 1 (XX.XX Hours) Solution 3 (0 HOURS)
S. No. Analyte Area IS Area Area Ratio S.NO Analyte Area IS Area Area Ratio
1 1
2 2
3 3
4 4
5 5
6 6
Mean Mean
Stability of the Stock = %
Result %

FOR INTERNAL STANDARD

Solution 2 (XX.XX Hours) Solution 3 (0 HOURS)
S. No. Analyte Area IS Area Area Ratio S.NO Analyte Area IS Area Area Ratio
1 1
2 2
3 3
4 4
5 5
6 6
Mean Mean
Stability of the Stock = %
Result %

ACCEPTANCE CRITERIA: The mean area ratio of the stored stock solution (room temperature) of analyte or IS
versus the refriegerated stock solution is within the range of 90 to 110%.

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: DRY EXTRACT STABILITY REFRIGERATOR
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(µg/mL)
Concentration
Calculated
(µg/mL)
Concentration

%Nominal

Result

0 Hour XX.XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)
Actual
Concentration
(µg/mL)

Calculated
Concentrations
(µg/mL)

Mean
SD
%CV
LIMIT
%Nominal

Result

%Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: DRY EXTRACT STABILITY ROOM TEMPERATURE
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(µg/mL)
Concentration
Calculated
(µg/mL)
Concentration
%Nominal

LIMIT

0 Hour XX.XX Hours

LQC HQC LQC HQC

(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(µg/mL)

Calculated
Concentrations
(µg/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%
Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: DRY EXTRACT STABILITY REFRIGERATOR
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

0 Hour XX.XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal

Result

%Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: DRY EXTRACT STABILITY ROOM TEMPERATURE
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

0 Hour XX.XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal

Result

%Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: FREEZE-THAW STABILITY - FT4
DATE :

Standard Units A B C D E F G H SLOPE

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

Comparison samples at -70ºC±15°C at -30º C±10°C

LQC HQC LQC HQC LQC HQC
CS CS FT4 FT4 FT4 FT4
Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
%Nominal against CS :
LIMIT
ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%
The accuracy for stability sample against
INTERCEPT r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: FREEZE-THAW STABILITY - FT4
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

at -70ºC±15°C at -30º C±10°C at -70ºC±15°C at -30º C±10°C

LQC HQC LQC HQC LQC HQC LQC HQC
CS CS CS CS FT4 FT4 FT4 FT4
Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
%Nominal against CS :
LIMIT
ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%
The accuracy for stability sample against
r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: BENCH TOP STABILITY
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(µg/mL)
Concentration
Calculated
(µg/mL)
Concentration
%Nominal

Result

0 Hour XX.XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(µg/mL)
ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%

Calculated The accuracy for stability sample against comparison sample

Concentrations is within ± 15%
(µg/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :

LIMIT
Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: BENCH TOP STABILITY
DATE :

INTERCEP
Standard Units A B C D E F G H I SLOPE
T
Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

Result

0 Hour XX.XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)
Actual
Concentration
(ng/mL)
ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
and the precision is ≤ 15%

Calculated The accuracy for stability sample against comparison sample

Concentrations is within ± 15%
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :

LIMIT
Prepared by Checked by
r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: AUTO SAMPLER STABILITY - ANALYTE
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(µg/mL)
Concentration

Calculated
(µg/mL)
Concentration
%Nominal

Result

0 Hour XX. XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)
Actual
Concentration
(µg/mL) ACCEPTANCE CRITERIA:

The accuracy for stability sample is within ± 15% and

the precision is ≤ 15%
Calculated
The accuracy for stability sample against comparison sample is
Concentrations
within ± 15%
(µg/mL)

Mean
SD
%CV
Result
%Nominal
Result
%Nominal against CS :
LIMIT

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: AUTO SAMPLER STABILITY - ANALYTE
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration

Calculated
(ng/mL)
Concentration
%Nominal

Result

0 Hour XX. XX Hours

LQC HQC LQC HQC
(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(ng/mL)
ACCEPTANCE CRITERIA:

The accuracy for stability sample is within ± 15% and

the precision is ≤ 15%
Calculated
The accuracy for stability sample against comparison sample is
Concentrations
within ± 15%
(ng/mL)

Mean
SD
%CV
Result
%Nominal

Result
%Nominal against CS :
LIMIT

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: AUTO SAMPLER STABILITY - INTERNAL STANDARD
DATE :

0 Hour XX.XX Hours

IS Area IS Area
(Fresh CS) (Stability)

LQC

HQC

Mean
% Stability against CS:
Result:

ACCEPTANCE CRITERIA:
The percentage stability of the Internal Standard should be between 85 to 115%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WET EXTRACT STABILITY ROOM TEMPERATURE
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT

Actual
(µg/mL)
Concentration
Calculated
(µg/mL)
Concentration
%Nominal

LIMIT

0 Hour XX.XX Hours

LQC HQC LQC HQC

(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(µg/mL)

Calculated
Concentrations
(µg/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%
Prepared by Checked by
r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WET EXTRACT STABILITY ROOM TEMPERATURE
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

LIMIT

0 Hour XX.XX Hours

LQC HQC LQC HQC

(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WET EXTRACT STABILITY - REFRIGERATOR
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(µg/mL)
Concentration
Calculated
(µg/mL)
Concentration
%Nominal

LIMIT

0 Hour XX.XX Hours

LQC HQC LQC HQC

(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(µg/mL)

Calculated
Concentrations
(µg/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: WET EXTRACT STABILITY - REFRIGERATOR
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

LIMIT

0 Hour XX.XX Hours

LQC HQC LQC HQC

(Fresh CS) (Fresh CS) (Stability) (Stability)

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS :
LIMIT

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15% and the precision is ≤ 15%
The accuracy for stability sample against comparison sample is within ± 15%

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: DILUTION INTEGRITY
DATE :

Standard Units A B C D E F G H SLOPE

Actual
Concentration (µg/mL)
Calculated
Concentration (µg/mL)
%Nominal

Result

2 TIMES 4 TIMES

Actual
Concentration
(µg/mL)

Calculated
Concentrations
(µg/mL)

Mean
SD
%CV
Limit
%Nominal
Result
ACCEPTANCE CRITERIA: FOR ACCURACY IS ± 15% AND THE PRECISION IS ≤ 15%

Prepared by Checked by
INTERCEPT r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: DILUTION INTEGRITY
DATE :

Standard Units A B C D E F G H I SLOPE

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration

%Nominal

Result

2 TIMES 4 TIMES

Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
Limit
%Nominal
Result
ACCEPTANCE CRITERIA: FOR ACCURACY IS ± 15% AND THE PRECISION IS ≤ 15%

Prepared by Checked by
INTERCEPT r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LONG TERM STOCK STABILITY at LQC level - ANALYTE
DATE :

ANALYTE Concentration of Concentration of IS Date

analyte (µg/mL) (µg/mL)
Stability Sample
Fresh

Solution 1 (XX Days) Solution 3 ( Fresh)

S. No. Analyte Area IS Area Area Ratio S. No. Analyte Area IS Area Area Ratio
1 1
2 2
3 3
4 4
5 5
6 6
Mean Mean
% Stability = %
Result
Calculation:

Analyte = Mean area ratio (analyte/IS) of the solution 1 X Concentration of fresh analyte stock X Concentration of stored IS stock X100
Mean area ratio (analyte/IS) of the solution 3 Concentration of stored analyte stock Concentration of fresh IS stock

Acceptance criteria:

The mean area ratio of the stored stock solution of analyte or IS

versus the freshly prepared stock solution is within the range of 90 to 110%

Prepared by: Checked by:

 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LONG TERM STOCK STABILITY at LQC level- INTERNAL STANDARD
DATE :

INTERNAL Concentration of Concentration of Date

STANDARD IS (µg/mL) analyte (µg/mL)
Stability Sample
Fresh

Solution 2 (XX Days) Solution 3 (Fresh)

S. No. Analyte Area IS Area Area Ratio S. No. Analyte Area IS Area Area Ratio
1 1
2 2
3 3
4 4
5 5
6 6
Mean Mean
% Stability = %
Result
Calculation:

IS = Mean area ratio (IS/analyte) of the solution 2 X Concentration of fresh IS stock X Concentration of stored analyte stock X 100
Mean area ratio (IS/analyte) of the solution 3 Concentration of stored IS stock Concentration of fresh analyte stock
IS = Internal standard

Acceptance criteria:

The mean area ratio of the stored stock solution of analyte or IS

versus the freshly prepared stock solution is within the range of 90 to 110%

Prepared by: Checked by:

 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LONG TERM STOCK STABILITY at HQC level- ANALYTE
DATE :

ANALYTE Concentration of Concentration of IS Date

analyte (µg/mL) (µg/mL)
Stability Sample 26.7220 10.0000 7-Mar-20
Fresh 26.7220 10.0000 1-Jul-20

Solution 1 (XX Days) Solution 3 ( Fresh)

S. No. Analyte Area IS Area Area Ratio S. No. Analyte Area IS Area Area Ratio
1 5334501 883768 6.0361 1 5835855 982249 5.9413
2 5243779 869688 6.0295 2 5916955 983058 6.0189
3 5270034 880307 5.9866 3 5865025 981359 5.9764
4 5258423 883150 5.9542 4 5817583 980577 5.9328
5 5289928 873790 6.0540 5 5740313 962122 5.9663
6 5291096 878687 6.0216 6 5710941 954785 5.9814
Mean 6.01367 Mean 5.96952
% Stability = %
Result
Calculation:

Analyte = Mean area ratio (analyte/IS) of the solution 1 X Concentration of fresh analyte stock X Concentration of stored IS stock X100
Mean area ratio (analyte/IS) of the solution 3 Concentration of stored analyte stock Concentration of fresh IS stock

Acceptance criteria:

The mean area ratio of the stored stock solution of analyte or IS

versus the freshly prepared stock solution is within the range of 90 to 110%

Prepared by: Checked by:

 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LONG TERM STOCK STABILITY at HQC level- - INTERNAL STANDAR
DATE :

INTERNAL Concentration of Concentration of Date

STANDARD IS (µg/mL) analyte (µg/mL)
Stability Sample
Fresh

Solution 2 (XX Days) Solution 3 (Fresh)

S. No. Analyte Area IS Area Area Ratio S. No. Analyte Area IS Area Area Ratio
1 5331042 888966 0.1668 1 5835855 982249 0.1683
2 5471120 908339 0.1660 2 5916955 983058 0.1661
3 5471948 916967 0.1676 3 5865025 981359 0.1673
4 5628575 937049 0.1665 4 5817583 980577 0.1686
5 5624346 937852 0.1667 5 5740313 962122 0.1676
6 5524900 918016 0.1662 6 5710941 954785 0.1672
Mean 0.16662 Mean 0.16752
% Stability = %
Result
Calculation:

IS = Mean area ratio (IS/analyte) of the solution 2 X Concentration of fresh IS stock X Concentration of stored analyte stock X 100
Mean area ratio (IS/analyte) of the solution 3 Concentration of stored IS stock Concentration of fresh analyte stock
IS = Internal standard

Acceptance criteria:

The mean area ratio of the stored stock solution of analyte or IS

versus the freshly prepared stock solution is within the range of 90 to 110%

Prepared by: Checked by:

 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LONG TERM STABILITY IN MATRIX
DATE :

Standard ID Units A B C D E F G H SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

0 Day XX Days XX Days

LQC HQC LQC HQC
LQC HQC stability sample stored stability sample stability sample stability sample
CS CS at stored at stored at stored at
-70ºC±15ºC -70ºC±15ºC -30ºC±10ºC -30ºC±10ºC
Actual
Concentration
(ng/mL)

Calculated
Concentrations
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
% Nominal against CS sample
LIMIT

Prepared by Checked by
r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LONG TERM STABILITY IN MATRIX
DATE :

Standard Units A B C D E F G H I SLOPE

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration

%Nominal

Result

0 Day XX Days XX Days

LQC HQC LQC HQC
LQC HQC stability sample stored stability sample stability sample stability sample
CS CS at stored at stored at stored at
-70ºC±15ºC -70ºC±15ºC -30ºC±10ºC -30ºC±10ºC
Actual
Concentration
(ng/mL) 56.7420 4613.1260 56.8240 4642.4900 56.8240 4642.4900
39.3364
38.4097
Calculated 52.3623
Concentrations
(ng/mL) 50.0722
58.4153
57.9940
Mean 49.43165
SD 8.791089
%CV 17.78
LIMIT Fail
%Nominal 87.12
LIMIT
% Nominal against CS sample
LIMIT

Prepared by Checked by
INTERCEPT
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: LIMIT OF DETECTION
DATE :

S/N Ratio of
LLOQ Dilution-01 Dilution-02 Dilution-03 LOD LOD
(≥5)

Analyte Area

Mean
0.000 Minimum
SD
%CV
0.000 Maximum
LIMIT

Prepared by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: INTERCONVERSION STABILITY
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

Result

Analyte and Analyte Cmax and

Co-Analyte Cmax Co-Analyte

LQC LQC
Actual Concentration (ng/mL)

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
Calculated Concentrations and the precision is ≤ 15%
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
Prepared by Checked by
r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: INTERCONVERSION STABILITY
DATE :

Standard Units A B C D E F G H I SLOPE

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal

Result

Anlayte and Anlayte Cmax and

Co-Analyte Cmax Co-Analyte

LQC LQC
Actual Concentration (ng/mL)

ACCEPTANCE CRITERIA:
The accuracy for stability sample is within ± 15%
Calculated Concentrations and the precision is ≤ 15%
(ng/mL)

Mean
SD
%CV
LIMIT
%Nominal
LIMIT
Prepared by Checked by
INTERCEPT r2
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: SELECTIVITY FOR "DRUG NAME"
DATE :

Standard Units A B C D E F G H SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LQC LQC LQC MQC MQC MQC HQC HQC HQC

Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal

LQC LQC LQC MQC MQC MQC HQC HQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: SELECTIVITY IN THE PRESENCE OF CONCOMITANT "DRUG NAME"
DATE :

Standard Units A B C D E F G H I SLOPE INTERCEPT r2

Actual
(ng/mL)
Concentration
Calculated
(ng/mL)
Concentration
%Nominal
Result

QC ID LQC LQC LQC MQC MQC MQC HQC HQC HQC

Actual
Concentration
(ng/mL)

Mean
SD
%CV
%Nominal

LQC LQC LQC MQC MQC MQC HQC HQC HQC

%CV Criteria
%NOMINAL Criteria

Prepared by Checked by
 MV NUMBER:
ANALYTE NAME:
EXPERIMENT: Internal Standard Instability
DATE :

Spiked LLOQ Peak Area

Analyte
IS

Spiked Internal Standard

Analyte / IS IS Analyte

Peak Area
Count

Minimum
Maximum

ACCEPTANCE CRITERIA:

i) In Spiked Internal standarad % analyte interference should be ≤20%

ii) In Spiked MQC , the % IS interfernce should be ≤5%

Prepared by
 Mean

Spiked Internal Standard Spiked MQC

% Analyte Interference % IS Interference
in Spiked IS Result Analyte IS peak in Spiked MQC
(≤20%) (≤5%)

0.00 0.00
0.00 0.00

Checked by
Result