RAW DATA CALCULATION SHEET

Brand Name-Assay (Active)

Std Area: 1447625 Std. Wt. : 12.5 mg Std Area: 1390264 Std. Wt. : 12.6 mg

System Precision Precision Day 02

Injection Retention Peak Area Injection Retention Peak Area

No. Time (min) (Active) No. Time (min) (Active)

1 4.20 1446002 1 4.66 1387409

2 4.23 1443660 2 4.66 1388843

3 4.25 1447134 3 4.69 1385992

4 4.25 1445674 4 4.66 1390366

5 4.28 1446952 5 4.66 1392446

6 4.30 1448601 6 4.70 1392177

Mean 4.25 1446337 Mean 4.67 1389539

% RSD 0.83 0.12 % RSD 0.39 0.19

Day 01 99.91
0.59
Day 02 100.75

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 RAW DATA CALCULATION SHEET
Brand Name-Assay (Active)

Repeatability

Injection %of stated Retention Peak Area

Mean % RSD
No. Conc Time (min) (Active)

1 80 4.39 1170928
2 80 4.37 1171114 1171047.667 0.01
3 80 4.38 1171101
1 100 4.56 1444615
2 100 4.56 1442739 1443507 0.07
3 100 4.55 1443167
1 120 4.39 1725627
2 120 4.38 1725977 1725926 0.02
3 120 4.39 1726173
Intermediate Precision

Injection %of stated Retention Peak Area

Mean % RSD
No. Conc Time (min) (Active)

1 80 4.81 1147928
2 80 4.81 1144234 1143667 0.40
3 80 4.81 1138840
1 100 4.69 1398157
2 100 4.69 1398279 1397855.667 0.05
3 100 4.69 1397131
1 120 4.69 1679012
2 120 4.69 1680651 1680023 0.05
3 120 4.69 1680406

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 RAW DATA CALCULATION SHEET
Brand Name-Assay (Active)

Standard wt= 62.6 mg Potency= 99.4%

Accuracy with placebo
Sample
added
No. of %of stated Peak area Peak area of Sample % of
Recovered Average
sample Conc of sample Standard (mg/ml) Recovery
(mg/ml)

1 80 0.100 1180119 0.1017 101.58

2 80 0.100 1181139 0.1018 101.66 102
3 80 0.100 1180148 0.1017 101.58
1 100 0.125 1464228 0.1262 100.82
2 100 0.125 1465223 1449938 0.1263 100.89 101
3 100 0.125 1465065 0.1263 100.88
1 120 0.150 1745740 0.1505 100.17
2 120 0.150 1741603 0.1501 99.94 100
3 120 0.150 1745725 0.1505 100.17

0.160 Chart Title

0.140 f(x) = 0.97070798x + 0.0046125057
Axis Title

Taken Recovered R² = 0.9999753144

0.120
0.100
0.100 0.102
0.080 Recovered
0.060 Linear
0.13 0.126 (Recovered)
0.040
0.020
0.15 0.150
0.000
0.0900.1000.1100.1200.1300.1400.1500.160
Axis Title

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 0.060 Linear
(Recovered)
0.040
RAW DATA CALCULATION SHEET
0.020
Brand Name-Assay (Active)
0.000
0.0900.1000.1100.1200.1300.1400.1500.160
Axis Title

Stock sol wt-62.5 mg

Linearity & Range for Active

Mean Peak
No. of %of Peak area
Conc Area
sampl stated
e Conc
(mg/ml) Linearity Chart for Brand Name
Active 2500000

741201
1 50 0.063 740866
740530 f(x) = 14246.1318965517x + 27286.0103448266
1171104 2000000 R² = 0.9998383029
2 80 0.100 1171025
1170945

Peak Area
1451542
3 100 0.125 1450183
1448824 1500000

1726338
4 120 0.150 1725994
1725650 Col umn E
2171519 1000000
5 150 0.188 2171429
2171339

Y intercept 27286
500000
% Y Intercept 1.88
Correlation
0.9998
coefficient
0
40 60 80 100 120 140 160
% of Nominal Concentration

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 RAW DATA CALCULATION SHEET
Brand Name-Assay (Active)
0
40 60 80 100 120 140 160
% of Nominal Concentration

Robustness Study

Paramet Theoretical Actual Retention Time(Mean) Tailing Factor(Mean)

Remarks
er Variance Variance Standard Sample Standard Sample
Flow 0.98 4.66 4.66 1.36 1.36
± 2.0 %
Rate 1.02 4.48 4.48 1.36 1.36
Organic 62.5 4.96 4.97 1.36 1.36 No significant effect
± 2.5% observed in
Ratio 67.5 4.23 3.53 1.35 1.35 robustness study.
Wavelen 252 4.57 4.57 1.36 1.36
±2 nm
gth 256 4.57 4.57 1.36 1.36

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RAW DATA CALCULATION SHEET
Brand Name-Assay (Active)

Y Intercept 0.0046125057
% Y Intercept 3.6524689712

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