Short Term Stock Solution Stability For ISTD Biology Essay

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Short term stock solution stability for the Analyte, Meatbolite-1 and Metabolite-2 at concentration (502195.891, 506796.797 and 503371.276 ng/mL respectively) was determined by using aqueous standard equivalent to SS HQC concentration of (502.196, 253.398 and 251.686 ng/mL) respectively, after a storage period of (21 hours 56 min, 21 hours 19 min and 21 hours 31 min for Analyte, Metabolite-1 and Metabolite-2) respectively, at room temperature. Stability was assessed by comparing against the freshly weighed stock concentration (50455.696, 506688.182 and 504936.519 ng/mL respectively) and prepared aqueous standard equivalent to SS HQC concentration of (502.536, 252.331 and 251.686 ng/mL) respectively. The % mean stability was found to be 99.51, 100.47 and 98.47 % for Analyte, Meatbolite-1 and Metabolite-2 respectively, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.16A, 6.16B & 6.16C.

Short term stock solution stability for ISTD at concentrations for Analyte, Meatbolite-1 and Metabolite-2 (97775.054 ng/mL) was determined by using ISTD dilution concentration (488.875 ng/mL) after a storage period of 21 hours 31 minutes at room temperature. Stability was assessed by comparing against the freshly weighed stock concentration for Analyte, Meatbolite-1 and Metabolite-2, (97747.645 ng/ml) was determined by using ISTD dilution concentration for Analyte, Meatbolite-1 and Metabolite-2 (488.738 ng/mL) respectively. The % mean stability was found to be 99.36, 99.65 and 99.67% respectively, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.16A, 6.16B & 6.16C.

Table 6.16A: Short Term Spiking Solution Stability for Analyte

 

Replicate No.

Analyte

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

502.536

502.196

488.738

488.875

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

3.1399

3.1119

3.1399

3.0765

2

3.0542

3.1109

3.0542

3.1285

3

3.1877

3.1157

3.1877

3.1815

4

3.2334

3.1787

3.2334

3.1244

5

3.2505

3.1187

3.2505

3.1699

6

3.1412

3.2650

3.1412

3.2106

n

6

6

6

6

Mean

3.16782

3.15015

3.16782

3.14857

SD

0.072013

0.061944

0.072013

0.048100

% CV

2.27

1.97

2.27

1.53

% Mean Stability

99.51

99.36

Table 6.16B: Short Term Spiking Solution Stability for Metabolite -1

 

 

 

 

Replicate No.

Analyte

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

252.331

253.398

488.738

488.875

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

0.8545

0.8628

0.8545

0.8327

2

0.8359

0.8654

0.8359

0.8697

3

0.8604

0.8580

0.8604

0.8847

4

0.8943

0.8836

0.8943

0.8455

5

0.8790

0.8721

0.8790

0.8420

6

0.8538

0.8824

0.8538

0.8864

n

6

6

6

6

Mean

0.86298

0.87072

0.86298

0.86017

SD

0.020658

0.010555

0.020658

0.023154

% CV

2.39

1.21

2.39

2.69

% Mean Stability

100.47

99.65

Table: 6.16C Short Term Spiking Solution Stability for Metabolite-2

 

Replicate No.

Analyte

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

251.458

251.686

488.738

488.875

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

1.1178

1.1464

1.1178

1.1400

2

1.1533

1.1627

1.1533

1.1458

3

1.1759

1.1153

1.1759

1.1901

4

1.1720

1.1589

1.1720

1.1471

5

1.1669

1.1270

1.1669

1.0995

6

1.1421

1.1365

1.1421

1.1847

n

6

6

6

6

Mean

1.15467

1.14113

1.15467

1.15120

SD

0.022000

0.018423

0.022000

0.033105

% CV

1.91

1.61

1.91

2.88

% Mean Stability

98.74

99.67

The proved Stock solution Stability was (21 hours 56 min, 21 hours 19 min, 21 hours31 min and 21 hours 40 min) for Analyte, Metabolite-1, Metabolite-2 and ISTD.

Acceptance criteria:

The % mean solution stability for drug and ISTD should be in the range of 90.00-110.00 %.

% CV of response ratio at each level should be ≤ 10.00 %

6.17 Short Term Spiking/Working Solution Stability:

Short term spiking solution stability for the Analyte, Meatbolite-1 and Metabolite-2 was determined by using aqueous standard equivalent to SS HQC (502.196, 253.398 and 251.686 ng/mL respectively) and SS LQC (1.788, 0.902 and 0.896 ng/mL respectively) concentration after a storage period of 21 hours 15 min at room temperature. Stability was assessed by comparing against the freshly weighed and prepared aqueous standard equivalent to SS HQC (502.536, 252.331 and 251.458 ng/mL respectively) and SS LQC (1.789, 0.898 and 0.895 ng/mL respectively) Concentrations. The % mean stability of HQC and LQC concentrations was found to be 100.50 and 98.00, 101.21 and 100.63, 101.05 and 96.23 % for Analyte, Meatbolite-1 and Metabolite-2 respectively, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.17A, 6.17B & 6.17C.

Short term ISTD dilution concentration (488.875 ng/mL) stability was determined after a storage period of 21 hours 15 mim, at room temperature. Stability was assessed by comparing against the freshly weighed and prepared ISTD dilution concentration (488.738 ng/mL). The % mean stability was found to be 100.60, 99.92 and 99.01 % respectively, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.17A, 6.17B & 6.17C.

Table 6.17A: Short Term Spiking / Working Solution Stability for Analyte and ISTD

Replicate

No.

HQC

LQC

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

502.536

502.196

1.789

1.788

488.738

488.875

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

3.1577

3.1423

0.0122

0.0118

3.1577

3.1881

2

3.1702

3.2312

0.0124

0.0121

3.1702

3.2709

3

3.1874

3.2341

0.0117

0.0119

3.1874

3.2444

4

3.2287

3.1383

0.0122

0.0119

3.2287

3.0927

5

3.1767

3.2275

0.0120

0.0118

3.1767

3.2653

6

3.1454

3.1747

0.0125

0.0120

3.1454

3.1243

n

6

6

6

6

6

6

Mean

3.17768

3.19135

0.01217

0.01192

3.17768

3.19762

SD

0.028968

0.045210

0.000288

0.000117

0.028968

0.075649

% CV

0.91

1.42

2.36

0.98

0.91

2.37

% Mean Stability

100.50

98.00

100.60

Table 6.17B: Short Term Spiking / Working Solution Stability for Metabolite-1 and ISTD

Replicate No.

HQC

LQC

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

252.331

253.398

0.898

0.902

488.738

488.875

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

0.8637

0.8436

0.0032

0.0032

0.8637

0.8875

2

0.8709

0.8995

0.0032

0.0032

0.8709

0.8556

3

0.8532

0.8962

0.0031

0.0031

0.8532

0.9106

4

0.8807

0.8800

0.0031

0.0031

0.8807

0.8579

5

0.8695

0.9030

0.0031

0.0030

0.8695

0.8552

6

0.8761

0.8773

0.0029

0.0032

0.8761

0.8447

n

6

6

6

6

6

6

Mean

0.86902

0.88327

0.00310

0.00313

0.86902

0.86858

SD

0.009684

0.022090

0.000110

0.000082

0.009684

0.025122

% CV

1.11

2.50

3.53

2.61

1.11

2.89

% Mean Stability

101.21

100.63

99.92

Table 6.17C: Short Term Spiking / Working Solution Stability for Metabolite-2 and ISTD

Replicate No.

HQC

LQC

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

251.458

251.686

0.895

0.896

488.738

488.875

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

1.1491

1.1316

0.0042

0.0040

1.1491

1.1498

2

1.1675

1.2045

0.0040

0.0039

1.1675

1.1676

3

1.1354

1.1631

0.0041

0.0042

1.1354

1.1371

4

1.1277

1.1411

0.0041

0.0040

1.1277

1.0900

5

1.1698

1.1619

0.0041

0.0036

1.1698

1.1480

6

1.1164

1.1418

0.0041

0.0040

1.1164

1.1072

n

6

6

6

6

6

6

Mean

1.14432

1.15733

0.00410

0.00395

1.14432

1.13328

SD

0.021655

0.026252

0.000063

0.000197

0.021655

0.029105

% CV

1.89

2.27

1.54

5.00

1.89

2.57

% Mean Stability

101.05

96.23

99.01

Short Term Working Solution Stability was proved at room temperature for 21 hours 15 min for analyte, Metabolite-1, Metabolite-2, and ISTD.

Acceptance Criteria:

The % mean solution stability for drug and ISTD should be in the range of 90.00-110.00 %.

% CV of response ratio at each level should be ≤ 10.00 %

6.18 Long Term Stock Solution Stability:

Long term stock solution stability for the Analyte, Meatbolite-1 and Metabolite2 at concentration (502333.565 , 505294.292 and 251.440 ng/mL) was determined by using aqueous standard equivalent to SS HQC concentration of 502.334 , 252.647 and 251.440 ng/mL respectively, after a storage period of 06 days 21 hours 20 min at 5 ± 3 °C. Stability was assessed by comparing against the freshly weighed stock concentration (502195.891, 506796.797 and 503371.276 ng/mL respectively) and prepared aqueous standard equivalent to SS HQC concentration of 502.196, 253.398 and 251.686 ng/mL respectively. The % mean stability was found to be 98.97, 102.82 and 100.10 for Analyte, Meatbolite-1 and Metabolite-2 respectively, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.18A, 6.18B &6.18C.

Long term stock solution stability for ISTD at concentration (97738.509 ng/mL) was determined by using ISTD dilution concentration 488.693 ng/mL after a storage period 06 days 21 hours 20 min at 5 ± 3 °C. Stability was assessed by comparing against the freshly weighed stock concentration (97775.054 ng/mL) was determined by using ISTD dilution concentration of 488.85 ng/mL. The % mean stability was found to be 98.44, 100.48 and 99.14 % for ISTD, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.18A, 6.18B &6.18C.

Table 6.18A: Long Term Stock Solution Stability for Analyte and Internal standard

Acquisition Batch ID

291110LTSS01

Date

29 Nov 2010

Replicate No.

Analyte

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

502.196

502.334

488.875

488.693

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

3.0670

3.0291

3.0670

3.0434

2

3.1066

3.1218

3.1066

3.1107

3

3.0956

3.0625

3.0956

3.0588

4

3.1110

3.0727

3.1110

3.0155

5

3.0982

3.1023

3.0982

3.0312

6

3.2437

3.1460

3.2437

3.1633

n

6

6

6

6

Mean

3.12035

3.08907

3.12035

3.07048

SD

0.062356

0.042562

0.062356

0.055980

% CV

2.00

1.38

2.00

1.82

% Mean Stability

98.97

98.44

Table 6.18B: Long Term Stock Solution Stability for Metabolite-1 and ISTD

Acquisition Batch ID

291110LTSS01

Date

29 Nov 2010

Replicate No.

Analyte

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

253.398

252.647

488.875

488.693

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

0.8608

0.8882

0.8608

0.8909

2

0.8471

0.8995

0.8471

0.8543

3

0.8758

0.8823

0.8758

0.8770

4

0.8750

0.8786

0.8750

0.8484

5

0.8363

0.8945

0.8363

0.8556

6

0.8862

0.8684

0.8862

0.8779

n

6

6

6

6

Mean

0.86353

0.88525

0.86353

0.86735

SD

0.019052

0.011262

0.019052

0.016891

% CV

2.21

1.27

2.21

1.95

% Mean Stability

102.82

100.48

Table 6.18C: Long Term Stock Solution Stability for Metabolite-2 and ISTD

Acquisition Batch ID

291110LTSS01

Date

29 Nov 2010

Replicate No.

Analyte

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

251.686

251.440

488.875

488.693

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

1.2101

1.1890

1.2101

1.1849

2

1.1882

1.2308

1.1882

1.1961

3

1.1777

1.1876

1.1777

1.1714

4

1.2057

1.2022

1.2057

1.1874

5

1.1874

1.1824

1.1874

1.1742

6

1.2065

1.1840

1.2065

1.1974

n

6

6

6

6

Mean

1.19593

1.19600

1.19593

1.18523

SD

0.013212

0.018428

0.013212

0.010808

% CV

1.10

1.54

1.10

0.91

% Mean Stability

100.10

99.14

Long Term Spiking Solution Stability was proved at 5 ± 3 °C, 06 days 20 hours 20 min for Analyte, Metabolite-1, Metabolite-2, and ISTD.

Acceptance Criteria:

The % mean solution stability for drug and ISTD should be in the range of 90.00-110.00 %.

% CV of response ratio at each level should be ≤ 10.00 %

6.19 Long Term Spiking Solution/Working Solution Stability:

Long term spiking solution stability for the Analyte, Meatbolite-1 and Metabolite-2 was determined by using aqueous standard equivalent to SS HQC (502.334, 252.647 and 251.440 ng/mL respectively) and SS LQC (1.790, 0.901 and 0.896 ng/mL respectively) concentration after a storage period of 06 days at 5 ± 3 °C. Stability was assessed by comparing against the freshly weighed and prepared aqueous standard equivalent to SS HQC (502.196, 253.398 and 251.686 ng/mL respectively) and SS LQC (1.788, 0.90 and 0.896 ng/mL respectively) concentrations. The % mean stability of Analyte, Meatbolite-1 and Metabolite-2 was found to be 101.37and101.44, 100.60 and 99.59, 100.73 and 99.08 for HQC and LQC concentrations respectively, which is within the acceptance limit of 90.00 - 110.00 %. The results are summarized in Tables 6.19A, 6.19B &6.19C.

Long term ISTD dilution concentration (488.693 ng/mL) stability was determined after a storage period of 06 days at 5 ± 3 °C. Stability was assessed by comparing against the freshly weighed and prepared ISTD dilution concentration (488.875 ng/mL). The % mean stability was found to be 101.09, 99.08 and 100.31 %, for ISTD, which is within the acceptance limit of 90.00 to 110.00 %. The results are summarized in Tables 6.19A, 6.19B &6.19C.

Table 6.19A: Long Term Spiking Solution/Working Solution Stability for Analyte and ISTD

Acquisition Batch ID

291110LTWS01

Date

29 Nov 2010

Replicate No.

HQC

LQC

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

502.196

502.334

1.788

1.790

488.875

488.693

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

3.1371

3.1618

0.0115

0.0123

3.1371

3.1663

2

3.0150

3.1363

0.0115

0.0121

3.0150

3.0552

3

3.0620

3.0880

0.0119

0.0120

3.0620

3.1186

4

3.1070

3.1154

0.0118

0.0118

3.1070

3.0703

5

3.1334

3.0886

0.0120

0.0118

3.1334

3.1363

6

3.0500

3.1735

0.0119

0.0117

3.0500

3.1533

n

6

6

6

6

6

6

Mean

3.08408

3.12727

0.01177

0.01195

3.08408

3.11667

SD

0.049376

0.036303

0.000216

0.000226

0.049376

0.044995

% CV

1.60

1.16

1.84

1.89

1.60

1.44

% Mean Stability

101.37

101.44

101.09

Table 6.19B: Long Term Spiking Solution/Working Solution Stability for Metabolite-1 and ISTD

Acquisition Batch ID

291110LTWS01

Date

29 Nov 2010

Replicate No.

HQC

LQC

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

253.398

252.647

0.902

0.901

488.875

488.693

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

0.8804

0.9010

0.0033

0.0033

0.8804

0.8678

2

0.8707

0.8817

0.0034

0.0032

0.8707

0.8553

3

0.8646

0.8628

0.0031

0.0032

0.8646

0.8628

4

0.8894

0.8759

0.0032

0.0033

0.8894

0.8723

5

0.8915

0.8888

0.0032

0.0032

0.8915

0.8856

6

0.8855

0.8876

0.0032

0.0031

0.8855

0.8879

n

6

6

6

6

6

6

Mean

0.88035

0.88297

0.00323

0.00322

0.88035

0.87195

SD

0.010714

0.012953

0.000103

0.000075

0.010714

0.012799

% CV

1.22

1.47

3.19

2.34

1.22

1.47

% Mean Stability

100.60

99.59

99.08

Table 6.19C: Long Term Spiking Solution/Working Solution Stability for Metabolite-2 and ISTD

Acquisition Batch ID

291110LTWS01

Date

29 Nov 2010

Replicate No.

HQC

LQC

ISTD

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

Nominal Concentration

ng/mL

251.686

251.440

0.896

0.896

488.875

488.693

Response Ratio

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

1.1586

1.1939

0.0042

0.0043

1.1586

1.1849

2

1.1726

1.2065

0.0043

0.0041

1.1726

1.1665

3

1.1683

1.1718

0.0044

0.0042

1.1683

1.1842

4

1.1785

1.1871

0.0043

0.0044

1.1785

1.1935

5

1.2092

1.1880

0.0044

0.0044

1.2092

1.1749

6

1.1853

1.1701

0.0044

0.0041

1.1853

1.1878

n

6

6

6

6

6

6

Mean

1.17875

1.18623

0.00433

0.00425

1.17875

1.18197

SD

0.017454

0.013726

0.000082

0.000138

0.017454

0.009693

% CV

1.48

1.16

1.88

3.24

1.48

0.82

% Mean Stability

100.73

98.08

100.31

LongTerm Working standard Solution Stability was proved at 5 ± 3 °C, 06 days 20 hours 20 min for Analyte, Metabolite-1, Metabolite-2, and ISTD.

Acceptance Criteria:

The % mean solution stability for drug and ISTD should be in the range of 90.00-110.00 %.

% CV of response ratio at each level should be ≤ 10.00 %

Stability of Analyte in Plasma:

Stability studies in plasma were conducted in various conditions using six replicates of LQC and HQC samples, as described below:

6.20 Freeze Thaw Stability at -28 ± 5 °C:

Freeze thaw stability of the spiked quality control samples was determined after four freeze thaw cycles stored at -28 ± 5 °C. Stability was assessed by comparing them against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to be 98.61 and 99.84, 101.94 and 97.31, 95.58 and 96.91 % respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.20A, 6.20B & 6.20C.

Table 6.20A: Freeze Thaw Stability of Analyte at -28 ± 5 °C

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

476.238

488.239

1.755

1.865

2

498.990

467.766

1.910

1.632

3

485.914

477.305

1.868

1.844

4

486.296

481.243

1.869

1.934

5

499.349

484.510

1.777

2.043

6

472.278

479.480

1.774

1.618

n

6

6

6

6

Mean

486.5108

479.7572

1.8255

1.8227

SD

11.21655

7.02306

0.06452

0.16819

% CV

2.31

1.46

3.53

9.23

%Mean Accuracy

96.85

95.51

101.98

101.82

% Mean Stability

98.61

99.84

Table 6.20B: Freeze Thaw Stability of Metabolite-1 at -28 ± 5 °C.

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

252.647

252.647

0.901

0.901

Nominal Concentration Range (ng/mL)

(214.750-290.544)

(214.750-290.544)

(0.766-1.036)

(0.766-1.036)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

254.854

255.956

0.921

0.919

2

270.323

255.539

0.932

0.887

3

261.658

278.410

0.910

0.946

4

252.744

258.823

0.934

0.877

5

261.126

275.761

0.931

0.865

6

245.759

251.943

0.830

0.817

n

6

6

6

6

Mean

257.7440

262.7387

0.9097

0.8852

SD

8.50859

11.35685

0.04005

0.04465

% CV

3.30

4.32

4.40

5.04

%Mean Accuracy

102.02

103.99

100.96

98.24

% Mean Stability

101.94

97.31

Table 6.20C: Freeze Thaw Stability of Metabolite-2 at -28 ± 5 °C

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

243.245

232.719

0.891

0.888

2

244.701

229.033

1.025

0.940

3

238.133

233.253

0.953

0.915

4

235.935

227.020

0.919

0.939

5

246.221

240.694

0.970

1.027

6

242.901

224.327

0.897

0.771

n

6

6

6

6

Mean

241.8560

231.1743

0.9425

0.9133

SD

3.97712

5.76300

0.05089

0.08390

% CV

1.64

2.49

5.40

9.19

%Mean Accuracy

96.19

91.94

105.19

101.93

% Mean Stability

95.58

96.91

6.21 Freeze Thaw Stability at -70 ± 10 °C:

Freeze thaw stability of the spiked quality control samples was determined after four freeze thaw cycles stored at 70 ± 10 °C. Stability was assessed by comparing them against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to be 98.15 and 100.12, 104.85 and 100.20, 94.98 and 91.76 % respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.21A, 6.21B & 6.21C.

Table 6.21A: Freeze Thaw Stability of Analyte at -70 ± 10 °C

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

476.238

483.571

1.755

1.667

2

498.990

480.500

1.910

1.851

3

485.914

473.791

1.868

1.871

4

486.296

480.270

1.869

1.875

5

499.349

477.922

1.777

1.868

6

472.278

468.983

1.774

1.834

n

6

6

6

6

Mean

486.5108

477.5062

1.8255

1.8277

SD

11.21655

5.29157

0.06452

0.08018

% CV

2.31

1.11

3.53

4.39

%Mean Accuracy

96.85

95.06

101.98

102.10

% Mean Stability

98.15

100.12

Table: 6.21B Freeze Thaw Stability of Metabolite -1 at -70 ± 10 °C

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

252.647

252.647

0.901

0.901

Nominal Concentration Range (ng/mL)

(214.750-290.544)

(214.750-290.544)

(0.766-1.036)

(0.766-1.036)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

254.854

269.153

0.921

0.833

2

270.323

266.779

0.932

0.828

3

261.658

274.411

0.910

0.958

4

252.744

270.167

0.934

1.073

5

261.126

280.084

0.931

0.863

6

245.759

260.797

0.830

0.914

n

6

6

6

6

Mean

257.7440

270.2318

0.9097

0.9115

SD

8.50859

6.58235

0.04005

0.09353

% CV

3.30

2.44

4.40

10.26

%Mean Accuracy

102.02

106.96

100.96

101.17

% Mean Stability

104.85

100.20

Table 6.21C: Freeze Thaw Stability of Metabolite -2 at -70 ± 10 °C

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(-28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

243.245

222.197

0.891

0.784

2

244.701

225.540

1.025

0.917

3

238.133

230.176

0.953

0.840

4

235.935

239.301

0.919

0.882

5

246.221

237.998

0.970

0.851

6

242.901

223.041

0.897

0.915

n

6

6

6

6

Mean

241.8560

229.7088

0.9425

0.8648

SD

3.97712

7.47268

0.05089

0.05074

% CV

1.64

3.25

5.40

5.87

%Mean Accuracy

96.19

91.36

105.19

96.52

% Mean Stability

94.98

91.76

Acceptance criteria:

At least 67 % (8 out of 12) of total QC samples and 50 % (3 out of 6) at each level in stability and comparison samples should be within 85.00 -115.00 %.

The % mean accuracy of back calculated concentration of LQC and HQC samples should be within 85.00-115.00 %.

The % CV of LQC and HQC samples should be ≤ 15.00 %.The % Mean Stability of LQC and HQC samples should be within 85.00-115.00 %.

6.22 Bench Top Stability:

Bench top stability of the spiked quality control samples was determined for a period of 13 hours 49 minutes stored at room temperature. Stability was assessed by comparing them against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to be 97.85 and 97.53, 102.29 and 106.08, 96.88 and 95.18% respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.22A, 6.22B & 6.22C.

Table 6.22A: Bench Top Stability for Analyte

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

480.171

470.432

1.822

1.743

2

497.792

495.532

1.831

1.766

3

490.527

476.639

1.814

1.690

4

495.954

480.863

1.785

1.748

5

499.717

472.172

1.799

1.730

6

474.550

479.777

1.711

1.819

n

6

6

6

6

Mean

489.7852

479.2358

1.7937

1.7493

SD

10.25571

8.97390

0.04370

0.04258

% CV

2.09

1.87

2.44

2.43

%Mean Accuracy

97.50

95.40

100.20

97.73

% Mean Stability

97.85

97.53

Table 6.22B: Bench Top Stability for Metabolite-1

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

252.647

252.647

0.901

0.901

Nominal Concentration Range (ng/mL)

(214.750-290.544)

(214.750-290.544)

(0.766-1.036)

(0.766-1.036)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

273.486

278.859

0.947

1.106

2

262.320

266.948

0.978

0.984

3

259.758

256.160

0.928

0.973

4

256.112

256.494

0.932

1.032

5

258.499

263.562

0.975

0.928

6

250.944

274.828

0.861

0.940

n

6

6

6

6

Mean

260.1865

266.1418

0.9368

0.9938

SD

7.56948

9.35092

0.04268

0.06603

% CV

2.91

3.51

4.56

6.64

%Mean Accuracy

102.98

105.34

103.98

110.30

% Mean Stability

102.29

106.08

Table 6.22C: Bench Top Stability for Metabolite-2

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

247.940

237.392

0.967

0.813

2

244.231

239.120

0.898

0.819

3

246.848

231.848

0.880

0.847

4

244.911

234.718

0.838

0.853

5

241.792

239.590

0.906

0.905

6

240.713

238.057

0.863

0.857

n

6

6

6

6

Mean

244.4058

236.7875

0.8920

0.8490

SD

2.80034

2.96490

0.04418

0.03291

% CV

1.15

1.25

4.95

3.88

%Mean Accuracy

97.20

94.17

99.55

94.75

% Mean Stability

96.88

95.18

Acceptance criteria:

At least 67 % (8 out of 12) of total QC samples and 50 % (3 out of 6) at each level in stability and comparison samples should be within 85.00 -115.00 %.

The % mean accuracy of back calculated concentration of LQC and HQC samples should be within 85.00-115.00 %.The % CV of LQC and HQC samples should be ≤ 15.00 %.The % Mean Stability of LQC and HQC samples should be within 85.00-115.00 %.

6.23 Autosampler Stability:

Autosampler stability of the processed quality control samples was determined for a period of 114 hours 31 minutes by storing them in autosampler maintained at temperature 5 ± 3 °C. Stability was assessed by comparing against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to 96.43 and 101.05, 99.03 and 106.49, 94.46 and 102.35% respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.23A, 6.23B & 6.23C.

Table 6.23A: Autosampler Stability for Analyte

Acquisition Batch

ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov

2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

480.171

470.255

1.822

1.792

2

497.792

479.481

1.831

1.893

3

490.527

476.377

1.814

1.707

4

495.954

469.691

1.785

1.866

5

499.717

467.364

1.799

1.838

6

474.550

470.502

1.711

1.779

n

6

6

6

6

Mean

489.7852

472.2783

1.7937

1.8125

SD

10.25571

4.62108

0.04370

0.06733

% CV

2.09

0.98

2.44

3.71

%Mean Accuracy

97.50

94.02

100.20

101.26

% Mean Stability

96.43

101.05

Table: 6.23B Autosampler Stability Metabolite -1:

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

252.647

252.647

0.901

0.901

Nominal Concentration Range (ng/mL)

(214.750-290.544)

(214.750-290.544)

(0.766-1.036)

(0.766-1.036)

Calculated Concentration (ng/mL)

Comparison Sample

Stability Samples

Comparison Samples

Stability Samples

1

273.486

265.808

0.947

1.001

2

262.320

272.916

0.978

1.113

3

259.758

254.350

0.928

0.982

4

256.112

256.665

0.932

1.008

5

258.499

260.650

0.975

0.949

6

250.944

235.609

0.861

0.933

n

6

6

6

6

Mean

260.1865

257.6663

0.9368

0.9977

SD

7.56948

12.69857

0.04268

0.06359

% CV

2.91

4.93

4.56

6.37

%Mean Accuracy

102.98

101.99

103.98

110.73

% Mean Stability

99.03

106.49

Table: 6.23C Autosampler Stability Metabolite -2:

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

247.940

233.139

0.967

0.889

2

244.231

233.000

0.898

0.912

3

246.848

228.964

0.880

0.928

4

244.911

237.807

0.838

0.963

5

241.792

230.193

0.906

0.883

6

240.713

222.033

0.863

0.903

n

6

6

6

6

Mean

244.4058

230.8560

0.8920

0.9130

SD

2.80034

5.29131

0.04418

0.02933

% CV

1.15

2.29

4.95

3.21

%Mean Accuracy

97.20

91.81

99.55

101.90

% Mean Stability

94.46

102.35

Acceptance criteria:

At least 67 % (8 out of 12) of total QC samples and 50 % (3 out of 6) at each level in stability and comparison samples should be within 85.00 -115.00 %.

The % mean accuracy of back calculated concentration of LQC and HQC samples should be within 85.00-115.00 %.

The % CV of LQC and HQC samples should be ≤ 15.00 %.The % Mean Stability of LQC and HQC samples should be within 85.00-115.00 %.

6.24 Wet Extract Stability at Room Temperature:

Wet extract stability of the spiked quality control samples was determined for a period of

05 hours 04 minutes by storing them at room temperature. Stability was assessed by comparing them against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to be 100.72 and 98.44, 103.04 and 97.23, 98.48 and 98.32 % respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.24A, 6.24B &6.24C.

Table 6.24A: Wet Extract Stability of Analyte at Room Temperature

Acquisition Batch ID

281110FCC02FQC02WERT01FT01(28±5)FT01 (-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

476.238

475.440

1.755

1.752

2

498.990

484.575

1.910

1.722

3

485.914

491.155

1.868

1.852

4

486.296

492.724

1.869

1.851

5

499.349

491.506

1.777

1.673

6

472.278

504.549

1.774

1.932

n

6

6

6

6

Mean

486.5108

489.9915

1.8255

1.7970

SD

11.21655

9.63452

0.06452

0.09715

% CV

2.31

1.97

3.53

5.41

%Mean Accuracy

96.85

97.54

101.98

100.39

%Mean Stability

100.72

98.44

Table 6.24B: Wet Extract Stability of Mtabolite-1 at Room Temperature

Acquisition Batch ID

281110FCC02FQC02WERT01FT01 (-28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

252.647

252.647

0.901

0.901

Nominal Concentration Range (ng/mL)

(214.750-290.544)

(214.750-290.544)

(0.766-1.036)

(0.766-1.036)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

254.854

267.013

0.921

0.852

2

270.323

256.170

0.932

0.835

3

261.658

259.377

0.910

0.953

4

252.744

270.784

0.934

1.009

5

261.126

275.461

0.931

0.756

6

245.759

264.596

0.830

0.902

n

6

6

6

6

Mean

257.7440

265.5668

0.9097

0.8845

SD

8.50859

7.13809

0.04005

0.09002

% CV

3.30

2.69

4.40

10.18

%Mean Accuracy

102.02

105.11

100.96

98.17

% Mean Stability

103.04

97.23

Table 6.24C: Wet Extract Stability of Mtabolite-2 at Room Temperature

Acquisition Batch ID

281110FCC02FQC02WERT01FT01 (-28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

243.245

233.838

0.891

0.903

2

244.701

233.473

1.025

0.959

3

238.133

241.583

0.953

0.883

4

235.935

233.330

0.919

0.979

5

246.221

247.141

0.970

0.820

6

242.901

239.651

0.897

1.016

n

6

6

6

6

Mean

241.8560

238.1693

0.9425

0.9267

SD

3.97712

5.63160

0.05089

0.07157

% CV

1.64

2.36

5.40

7.72

%Mean Accuracy

96.19

94.72

105.19

103.42

% Mean Stability

98.48

98.32

Acceptance criteria:

At least 67 % (8 out of 12) of total QC samples and 50 % (3 out of 6) at each level in stability and comparison samples should be within 85.00 -115.00 %.

The % mean accuracy of back calculated concentration of LQC and HQC samples should be within 85.00-115.00 %.

The % CV of LQC and HQC samples should be ≤ 15.00 %.The % Mean Stability of LQC and HQC samples should be within 85.00-115.00 %.

6.25 Wet Extract Stability at Refrigerated Temperature:

Wet extract stability of the spiked quality control samples was determined for a period of 109 hours 15 min by storing them at 5 ± 3 °C. Stability was assessed by comparing them against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to be 97.48 and 99.38, 98.48 and 98.32, 95.34 and 96.92 % respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.25A, 6.25B & 6.25C.

Table 6.25A: Wet Extract Stability of Analyte at Refrigerated Temperature

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

480.171

465.994

1.822

1.719

2

497.792

472.624

1.831

1.690

3

490.527

477.259

1.814

1.907

4

495.954

467.865

1.785

1.808

5

499.717

502.180

1.799

1.766

6

474.550

478.642

1.711

1.805

n

6

6

6

6

Mean

489.7852

477.4273

1.7937

1.7825

SD

10.25571

13.11053

0.04370

0.07683

% CV

2.09

2.75

2.44

4.31

%Mean Accuracy

97.50

95.04

100.20

99.58

% Mean Stability

97.48

99.38

Table 6.25B: Wet Extract Stability of Metabolite-1 at Refrigerated Temperature

Acquisition Batch ID

281110FCC02FQC02WERT01FT01 (-28±5)FT01(-70±10)

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

0.7621.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

243.245

233.838

0.891

0.903

2

244.701

233.473

1.025

0.959

3

238.133

241.583

0.953

0.883

4

235.935

233.330

0.919

0.979

5

246.221

247.141

0.970

0.820

6

242.901

239.651

0.897

1.016

n

6

6

6

6

Mean

241.8560

238.1693

0.9425

0.9267

SD

3.97712

5.63160

0.05089

0.07157

% CV

1.64

2.36

5.40

7.72

%Mean Accuracy

96.19

94.72

105.19

103.42

%Mean Stability

98.48

98.32

Table 6.25C: Wet Extract Stability of Metabolite-2 at Refrigerated Temperature

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01 ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

247.940

233.806

0.967

0.841

2

244.231

228.482

0.898

0.887

3

246.848

246.145

0.880

0.873

4

244.911

225.926

0.838

0.878

5

241.792

232.756

0.906

0.767

6

240.713

230.940

0.863

0.941

n

6

6

6

6

Mean

244.4058

233.0092

0.8920

0.8645

SD

2.80034

7.04552

0.04418

0.05774

% CV

1.15

3.02

4.95

6.68

%Mean Accuracy

97.20

92.67

99.55

96.48

% Mean Stability

95.34

96.92

Acceptance criteria:

At least 67 % (8 out of 12) of total QC samples and 50 % (3 out of 6) at each level in stability and comparison samples should be within 85.00 -115.00 %.

The % mean accuracy of back calculated concentration of LQC and HQC samples should be within 85.00-115.00 %.

The % CV of LQC and HQC samples should be ≤ 15.00 %.The % Mean Stability of LQC and HQC samples should be within 85.00-115.00 %.

6.26 Dry Extract Stability:

Dry extract stability of the spiked quality control samples was determined for a period of 109 hours 40 minutes by storing them at -20 ± 5 °C. Stability was assessed by comparing them against the freshly spiked calibration standards and quality control samples. The % mean stability of Analyte, Metabolite-1 and Metabolite-2 for HQC and LQC was found to be 98.58 and 96.98, 97.78 and 100.32, 96.09 and 94.13 % respectively, which is within the acceptance limit of 85.00 - 115.00 %. The results are summarized in Tables 6.26A, 6.26B & 6.26C.

Table6.26A: Dry Extract Stability for Analyte

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

502.334

502.334

1.790

1.790

Nominal Concentration Range (ng/mL)

(426.984-577.684)

(426.984-577.684)

(1.522-2.059)

(1.522-2.059)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

480.171

471.579

1.822

1.763

2

497.792

485.592

1.831

1.672

3

490.527

485.957

1.814

1.934

4

495.954

484.998

1.785

1.829

5

499.717

486.108

1.799

1.724

6

474.550

482.878

1.711

1.515

n

6

6

6

6

Mean

489.7852

482.8520

1.7937

1.7395

SD

10.25571

5.64689

0.04370

0.14254

% CV

2.09

1.17

2.44

8.19

%Mean Accuracy

97.50

96.12

100.20

97.18

% Mean Stability

98.58

96.98

Table 6.26B: Dry Extract Stability for Metabolite-1

Acquisition Batch

ID

281110FCC01FQC01DE01BT01WERF01 ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

252.647

252.647

0.901

0.901

Nominal Concentration Range (ng/mL)

(214.750-290.544)

(214.750-290.544)

(0.766-1.036)

(0.766-1.036)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

273.486

251.604

0.947

0.957

2

262.320

247.774

0.978

0.866

3

259.758

248.739

0.928

1.009

4

256.112

246.208

0.932

0.989

5

258.499

258.452

0.975

0.924

6

250.944

273.684

0.861

0.894

n

6

6

6

6

Mean

260.1865

254.4102

0.9368

0.9398

SD

7.56948

10.38430

0.04268

0.05532

% CV

2.91

4.08

4.56

5.89

%Mean Accuracy

102.98

100.70

103.98

104.31

% Mean Stability

97.78

100.32

Table 6.26C: Dry Extract Stability for Metabolite-2

Acquisition Batch ID

281110FCC01FQC01DE01BT01WERF01ASS01

Date

28 Nov 2010

Replicate No.

HQC

LQC

Nominal Concentration (ng/mL)

251.440

251.440

0.896

0.896

Nominal Concentration Range (ng/mL)

(213.724-289.156)

(213.724-289.156)

(0.762-1.030)

(0.762-1.030)

Calculated Concentration (ng/mL)

Comparison Samples

Stability Samples

Comparison Samples

Stability Samples

1

247.940

235.637

0.967

0.865

2

244.231

239.675

0.898

0.880

3

246.848

239.916

0.880

0.891

4

244.911

231.999

0.838

0.866

5

241.792

230.751

0.906

0.804

6

240.713

231.185

0.863

0.732

n

6

6

6

6

Mean

244.4058

234.8605

0.8920

0.8397

SD

2.80034

4.19347

0.04418

0.06076

% CV

1.15

1.79

4.95

7.24

%Mean Accuracy

97.20

93.41

99.55<

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