ANIMAL PRODUCTS, VETERINARY

DRUG ETHIOPIA AGRICULTURAL

AND FEED QUALITY ASSESSMENT AUTHORITY
CENTRE
Certificate No.
Tel: + 251-11-471-79-64 Tel: + 251-11-551-92-29 QMS_DQA_1313_01/11/2022
+ 251-11-471-72-58 + 251-11-552-40-45
P.O.Box: 31303 + 251-11-550-66-93
Addis Ababa, Ethiopia P.O.Box: 31303 Addis Ababa, Ethiopia

DRUG PHYSICOCHEMICAL TEST RESULT REPORTING FORM QMS_FORM_013

1.       SAMPLE INFORMATION

Sample submission date Oct.27/2022 Sampling method -

Sample ID DRS_1313_2022 Customer Ref. No A/M/0059/15

Brand Name TETRACOZASH C Generic name Oxyclozanide + Levamisole HCl

Formulation Bolus Presentation 40 Boli/Box

Oxyclozanide 1400mg + Levamisole
Composition Batch/Lot No. ALT-9583
HCl 1000mg
Mfg. Date Jul. 31/2022 Expiry Date June. 01/2026
OROMIA AGRICULTURAL COOPERATIVE
Manufacturer Ashish Life Science For the account of
FEDERETION LTD
Country of origin India Test purpose Consigment check
Submitted by EAA-BOD Method of analysis Manufacturer

Analysis request date 27/10/2022 Date reported Nov. 1 /2022

2.       PHYSICOCHEMICAL TEST RESULTS

Analysis
Test parameters Specification/acceptance limit Observation Conclusion
date
It is a Pink coloured elongated
A Pink coloured elongated biconvex uncoted
biconvex uncoted bolus having
Appearance bolus having break line on one side and emboss Complies
break line on one side and emboss
ALS on other side of each bolus.
ALS on other side of each bolus.
The light absorption in the range
Identification Test for The light absorption in the range 250-to 200nm of
250-to 200nm of solution exhibits a Complies
Levamisole HCl solution exhibits a maxima at about 214nm
27- maxima at about 214.1nm
31/10/2022 The light absorption in the range
Identification Test for The light absorption in the range 260-to 350nm of
260-to 350nm of solution exhibits a Complies
Oxyclozanide solution exhibits a maxima at about 300nm
maxima at about 301nm

Assay Levamisole HCl 95.0 -105.0 % of the labeled amount 104.3% Complies

Assay of Oxyclozanide 95.0 -105.0 % of the labeled amount 102.9% Complies

3.    GENERAL CONCLUSION: The Tested sample meets the requirements as per the manufacturer method.

4. REMARK: This report and its test results relates only to the specified sample identified here in and do not apply to any similar item that has not been tested

5.    FINAL TEST RESULT AUTHORIZATION

Final test report Name Signature Date
Analysed by Dinsefa J (Dr)

Reviewed by Gudeta U.

APVDFQAC Quality Assurance Page 1 of 1

Approved by

APVDFQAC Quality Assurance Page 1 of 1

 ANIMAL PRODUCTS, VETERINARY
DRUG ETHIOPIA AGRICULTURAL
AND FEED QUALITY ASSESSMENT AUTHORITY
CENTRE
Certificate No.
Tel: + 251-11-471-79-64 Tel: + 251-11-551-92-29 QMS_DQA_1314_01/11/2022
+ 251-11-471-72-58 + 251-11-552-40-45
P.O.Box: 31303 + 251-11-550-66-93
Addis Ababa, Ethiopia P.O.Box: 31303 Addis Ababa, Ethiopia

DRUG PHYSICOCHEMICAL TEST RESULT REPORTING FORM QMS_FORM_013

1.       SAMPLE INFORMATION

Sample submission date Oct.27/2022 Sampling method -

Sample ID DRS_1314_2022 Customer Ref. No A/M/0059/15

Brand Name TETRACOZASH C Generic name oxyclozanide + Levamisole HCl

Formulation Bolus Presentation 40 Boli/Box

oxyclozanide 1400mg + Levamisole
Composition Batch/Lot No. ALT-9584
HCl 1000mg/bolus
Mfg. Date Jul. 31/2022 Expiry Date June. 01/2026
OROMIA AGRICULTURAL COOPERATIVE
Manufacturer Ashish Life Science For the account of
FEDERETION LTD
Country of origin India Test purpose Consigment check
Submitted by EAA-BOD Method of analysis Manufacturer

Analysis request date 27/10/2022 Date reported Nov. 1 /2022

2.       PHYSICOCHEMICAL TEST RESULTS

Analysis
Test parameters Specification/acceptance limit Observation Conclusion
date
It is a Pink coloured elongated
A Pink coloured elongated biconvex uncoted
biconvex uncoted bolus having
Appearance bolus having break line on one side and emboss Complies
break line on one side and emboss
ALS on other side of each bolus.
ALS on other side of each bolus.
The light absorption in the range
Identification Test for The light absorption in the range 250-to 200nm of
250-to 200nm of solution exhibits a Complies
Levamisole HCl solution exhibits a maxima at about 214nm
27- maxima at about 214.1nm
31/10/2022 The light absorption in the range
Identification Test for The light absorption in the range 260-to 350nm of
260-to 350nm of solution exhibits a Complies
Oxyclozanide solution exhibits a maxima at about 300nm
maxima at about 300.1nm

Assay Levamisole HCl 95.0 -105.0 % of the labeled amount 104.7% Complies

Assay of Oxyclozanide 95.0 -105.0 % of the labeled amount 102.9% Complies

3.    GENERAL CONCLUSION: The Tested sample meets the requirements as per the manufacturer method.

4. REMARK: This report and its test results relates only to the specified sample identified here in and do not apply to any similar item that has not been tested

5.    FINAL TEST RESULT AUTHORIZATION

Final test report Name Signature Date
Analysed by Dinsefa J (Dr)

Reviewed by Gudeta U.

APVDFQAC Quality Assurance Page 1 of 1

Approved by

APVDFQAC Quality Assurance Page 1 of 1