Physicochemical Laboratory Services Directorate

Drug Physicochemical Analysis Case Team

Worksheet for Assay By UV-VIS Spectrophotometry
1. Sample and Reference Details
Sample ID QMS_DQA_1313_2022

Sample Name Levamisole HCl 1000mg

Generic Name Oxyclozanide 1400 mg+ Levamisole 1000mg

Reference Material Levamisole USP I.D QMS_RMS_1067-2022

Sample Description A Pink coloured elongated biconvex uncoted bolus having break line on one side and emboss ALS on other

2. Method Details

Method Manufacturer

Instruments UV-VIS

Cuvette No. 1

Scan range, if aquired 200-250 nm

Filter paper pore size 0.45

Detection wavelength 300 nm

Diluting Solution 0.85ml Hcl with 1000ml purified water

3. Result

3.1 For Liquid preparations Only 3.2 For Solid Preparation

Mass of 5 tablets (g) 31.226

Specific Gravity 1
Mean Mass (mg) 6245.2

3.3 Weight and Peak Areas

Reference Standard Preparation Sample Preparation

Std. 1 Std. 2 A B C
Amount (mg) 25.01 25.01 325.01 325.01 325.02
Absorbance 1 0.9112 0.9106 0.9851 0.9878 0.9939
Absorbance 2 0.9112 0.9106 0.9871 0.9863 0.9934
Absorbance 3 0.9106 0.9106 0.9867 0.9865 0.9929
Mean Absorbance 0.9110 0.9106 0.9863 0.9869 0.9934

Mean Absorbance of Std 1/2) 0.91080

Analyst : Dinsefa J (Dr) Checked by : Gudeta U.

Page 1 of 8
4. Calculations
4.1 System Suitability Result N/A
4.2 Reference Standard
Potency Calculation
Potency on label 99.9
Water content/LOD (in decimal) 0
Mol. Weight of API in Sample 1
Mol. Weight of Reference Standard 1
Potency of Reference used 0.999
Standard Dilution Factor 2500
Standard concentration 0.010004

4.3 Sample Dilution

Sample Dilution Factor 5000
Stated amount 1000 mg/ Bolus
4.4 Percentage of Active Content

%Content = Abs. sple*Std conc*Potency*Sample dil factor*Mean mass* SG*100

Abs. std * amt of sple used * label claim

%Content A 103.98
%Content B 104.04
%Content C 104.72

% Mean content 104.25

%RSD 0.40

Specifications: Content 95.0%-105.0%

%RSD NMT 2.0%

5. Conclusion complies

1 Complies If RSD and % content are within Specifications

2 Does not comply If RSD is within Specifications but % content is outside
3 Invalid If RSD is out of specification regardless of the result of % content
The sample (complies, does not comply) to the specification (Insert one if either 1 or 2
The test data is (invalid) and re-test is required.

Analyst : Dinsefa J (Dr) Checked by : Gudeta U.

Page 2 of 8
 Physicochemical Laboratory Services Directorate
Drug Physicochemical Analysis Case Team
Worksheet for Assay By UV-VIS Spectrophotometry
1. Sample and Reference Details
Sample ID QMS_DQA_1313_2022

Sample Name Oxyclozanide 1400mg

Generic Name Oxyclozanide 1400 mg+ Levamisole 1000mg

Reference Material WS Oxyclozanide I.D QMS_RMS_821-2021

Sample Description A Pink coloured elongated biconvex uncoted bolus having break line on one side and emboss ALS on other

2. Method Details

Method Manufacturer

Instruments UV-VIS

Cuvette No. 1

Scan range, if aquired 260-350 nm

Filter paper pore size 0.45

Detection wavelength 300 nm

Diluting Solution 900ml Methanol 18ml glacial acetic acid diluted to 1000ml with water

3. Result

3.1 For Liquid preparations Only 3.2 For Solid Preparation

Mass of 5 tablets (g) 31.226

Specific Gravity 1
Mean Mass (mg) 6245.2

3.3 Weight and Peak Areas

Reference Standard Preparation Sample Preparation

Std. 1 Std. 2 A B C
Amount (mg) 60.01 60.01 278.01 278 278.01
Absorbance 1 0.7492 0.7475 0.8058 0.8046 0.8068
Absorbance 2 0.7487 0.7475 0.8059 0.8041 0.8065
Absorbance 3 0.7485 0.7467 0.8056 0.8041 0.8063
Mean Absorbance 0.7488 0.7472 0.8058 0.8043 0.8065

Mean Absorbance of Std 1/2) 0.74802

Dinsefa J (Dr) Checked by : Gudeta U.

Page 3 of 8
4. Calculations
4.1 System Suitability Result N/A
4.2 Reference Standard
Potency Calculation
Potency on label 99.25
Water content/LOD (in decimal) 0
Mol. Weight of API in Sample 1
Mol. Weight of Reference Standard 1
Potency of Reference used 0.9925
Standard Dilution Factor 2000
Standard concentration 0.030005

4.3 Sample Dilution

Sample Dilution Factor 2000
Stated amount 1400 mg/ Bolus
4.4 Percentage of Active Content

%Content = Abs. sple*Std conc*Potency*Sample dil factor*Mean mass* SG*100

Abs. std * amt of sple used * label claim

%Content A 102.95
%Content B 102.76
%Content C 103.04

% Mean content 102.92

%RSD 0.14

Specifications: Content 95.0%-105.0%

%RSD NMT 2.0%

5. Conclusion complies

1 Complies If RSD and % content are within Specifications

2 Does not comply If RSD is within Specifications but % content is outside
3 Invalid If RSD is out of specification regardless of the result of % content
The sample (complies, does not comply) to the specification (Insert one if either 1 or 2
The test data is (invalid) and re-test is required.

Analyst : Dinsefa J (Dr) Checked by : Gudeta U.

Page 4 of 8
 Physicochemical Laboratory Services Directorate
Drug Physicochemical Analysis Case Team
Worksheet for Assay By UV-VIS Spectrophotometry
1. Sample and Reference Details
Sample ID QMS_DQA_1314_2022

Sample Name Oxyclozanide 1400mg

Generic Name Oxyclozanide 1400 mg+ Levamisole 1000mg

Reference Material WS Oxyclozanide I.D QMS_RMS_821-2021

Sample Description A Pink coloured elongated biconvex uncoted bolus having break line on one side and emboss ALS on other

2. Method Details

Method Manufacturer

Instruments UV-VIS

Cuvette No. 1

Scan range, if aquired 260-350 nm

Filter paper pore size 0.45

Detection wavelength 300 nm

Diluting Solution 900ml Methanol 18ml glacial acetic acid diluted to 1000ml with water

3. Result

3.1 For Liquid preparations Only 3.2 For Solid Preparation

Mass of 5 tablets (g) 31.3225

Specific Gravity 1
Mean Mass (mg) 6264.5

3.3 Weight and Peak Areas

Reference Standard Preparation Sample Preparation

Std. 1 Std. 2 A B C
Amount (mg) 60.01 60.01 278.04 278.03 278.05
Absorbance 1 0.7492 0.7475 0.8065 0.8053 0.7988
Absorbance 2 0.7487 0.7475 0.8059 0.8051 0.7987
Absorbance 3 0.7485 0.7467 0.806 0.8048 0.7985
Mean Absorbance 0.7488 0.7472 0.8061 0.8051 0.7987

Mean Absorbance of Std 1/2) 0.74802

Dinsefa J (Dr) Checked by : Gudeta U.

Page 5 of 8
4. Calculations
4.1 System Suitability Result N/A
4.2 Reference Standard
Potency Calculation
Potency on label 99.25
Water content/LOD (in decimal) 0
Mol. Weight of API in Sample 1
Mol. Weight of Reference Standard 1
Potency of Reference used 0.9925
Standard Dilution Factor 2000
Standard concentration 0.030005

4.3 Sample Dilution

Sample Dilution Factor 2000
Stated amount 1400 mg/ Bolus
4.4 Percentage of Active Content

%Content = Abs. sple*Std conc*Potency*Sample dil factor*Mean mass* SG*100

Abs. std * amt of sple used * label claim

%Content A 103.30
%Content B 103.17
%Content C 102.34

% Mean content 102.94

%RSD 0.51

Specifications: Content 95.0%-105.0%

%RSD NMT 2.0%

5. Conclusion complies

1 Complies If RSD and % content are within Specifications

2 Does not comply If RSD is within Specifications but % content is outside
3 Invalid If RSD is out of specification regardless of the result of % content
The sample (complies, does not comply) to the specification (Insert one if either 1 or 2
The test data is (invalid) and re-test is required.

Analyst : Dinsefa J (Dr) Checked by : Gudeta U.

Page 6 of 8
 Physicochemical Laboratory Services Directorate
Drug Physicochemical Analysis Case Team
Worksheet for Assay By UV-VIS Spectrophotometry
1. Sample and Reference Details
Sample ID QMS_DQA_1314_2022

Sample Name Levamisole HCl1000mg

Generic Name Oxyclozanide 1400 mg+ Levamisole 1000mg

Reference Material Levamisole USP I.D QMS_RMS_1067-2022

Sample Description A Pink coloured elongated biconvex uncoted bolus having break line on one side and emboss ALS on other

2. Method Details

Method Manufacturer

Instruments UV-VIS

Cuvette No. 1

Scan range, if aquired 200-250 nm

Filter paper pore size 0.45

Detection wavelength 300 nm

Diluting Solution 0.85ml Hcl with 1000ml purified water

3. Result

3.1 For Liquid preparations Only 3.2 For Solid Preparation

Mass of 5 tablets (g) 31.3225

Specific Gravity 1
Mean Mass (mg) 6264.5

3.3 Weight and Peak Areas

Reference Standard Preparation Sample Preparation

Std. 1 Std. 2 A B C
Amount (mg) 25.01 25.01 326.01 326.01 326.02
Absorbance 1 0.9112 0.9106 0.994 0.9931 0.9932
Absorbance 2 0.9112 0.9106 0.9934 0.9932 0.993
Absorbance 3 0.9106 0.9106 0.9933 0.9931 0.9933
Mean Absorbance 0.9110 0.9106 0.9936 0.9931 0.9932

Mean Absorbance of Std 1/2) 0.91080

Dinsefa J (Dr) Checked by : Gudeta U.

Page 7 of 8
4. Calculations
4.1 System Suitability Result N/A
4.2 Reference Standard
Potency Calculation
Potency on label 99.9
Water content/LOD (in decimal) 0
Mol. Weight of API in Sample 1
Mol. Weight of Reference Standard 1
Potency of Reference used 0.999
Standard Dilution Factor 2500
Standard concentration 0.010004

4.3 Sample Dilution

Sample Dilution Factor 5000
Stated amount 1000 mg/ Bolus
4.4 Percentage of Active Content

%Content = Abs. sple*Std conc*Potency*Sample dil factor*Mean mass* SG*100

Abs. std * amt of sple used * label claim

%Content A 104.75
%Content B 104.70
%Content C 104.70

% Mean content 104.72

%RSD 0.03

Specifications: Content 95.0%-105.0%

%RSD NMT 2.0%

5. Conclusion complies

1 Complies If RSD and % content are within Specifications

2 Does not comply If RSD is within Specifications but % content is outside
3 Invalid If RSD is out of specification regardless of the result of % content
The sample (complies, does not comply) to the specification (Insert one if either 1 or 2
The test data is (invalid) and re-test is required.

Analyst : Dinsefa J (Dr) Checked by : Gudeta U.

Page 8 of 8