109 North Main Ave., Laguna Technopark, Biflan, Laguna, Philippines 4024 £48. LaBonAroRies, ie. CERTIFICATE OF ANALYSIS (FINISHED PRODUCT) CLARITHROCID 125 mg /5 mL GFS Manufactured for |The Cathay Drug Co., Ine. |UHeoretical Yield | 4,320 bots x 50 mL ‘Actual Yield 4,250 bots x 50 mL Lot Number 171285 D.R. Number DRP-3604 Manufacturing Date [Dee 2016 Certificate No. | CLA-GS-125-000-16-26 Expiration Date _ [Dee 2018 Document No COA-QFP-GS-26 Test Requirements Specifications Result . Packaging Component . Description of Granules |. Identification Test . Loss on Drying 1.1 Primary 1.2 Secondary 1.3 Accessories 2.1 Color 2.2 Odor Description of Reconstituted Granules 3.1 Consistency 3.2 Color 3.3 Flavor 50 mL Opaque white plastic bottle with white pilfer proof snap plastic cap Printed sticker label and printed unit box with security seal Printed package insert and 20-mL plastic measuring cup Light pink Cherry Suspension Pink Cherry The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard Preparation, as obtained in the Assay. ‘Not more than 2.0% Conforms Conforms Conforms Light Pink With a characteristic cherry flavor Suspension Pink Cherry Conforms 1.2% Page 1 of 3 page/s Tel, No.: (049) 541-3222; Fax No: (049) 541-3288; Cell. No. 0927-9704037 Email: ga@el-laboratories.comLasonarories, ic. 109 North Main Ave., Laguna Technopark, Bifan, Laguna, Philippines 4024 CERTIFICATE OF ANALYSIS (FINISHED PRODUCT) CLARITHROCID 125 mg /5 mL GFS ‘Theoretical Yield Manufactured for |The Cathay Drug Co., Ine. |e 18 4,520 bets x 50 mi. Actual Yield 4,250 bots x 50 mL Lot Number 171253 DR. Number DRP-3604 Manufacturing Date |Dee 2016 Certificate No. | CLA-GS-125-000-16-26 Expiration Date | Dee 2018 Document No, COA-QFP-GS26 ‘Test Requirements Specifications Result 6. pHof Reconstituted | Between 4.0 and 5.4 53 Suspension 7. Deliverable Volume _| The average volume of reconstituted suspension 50.0 mL obtained from 10 containers is not less than 50.0 ml (100.0%), and no container has a volume less than 47.5 mL (95.0%) of the declared volume on the label. 8. Uniformity of Dosage Units 8.1 Content Uniformity | Acceptance value is less than or equal to 15.0%. 11.6% 8.2 Weight Range 23.185 g + 10% (20.867g - 25.504g) 22.888g-23.913g 9. Assay Not less than 90.0% and not more than 115.0% 109.7% of 125 mg Clarithromycin per 5 mL suspension. Reference | Method Transfer, In-House Action RELEASED Page 2 of 3 page/s Tel. No. (049) 541-3222; Fax No:: (049) 641-2288; Cell. No. 0927-9704037 Email: ga@el-laboratories.comBifian, Laguna, Philippines 4024 CERTIFICATE OF ANALYSIS (FINISHED PRODUCT) Co CLARITHROCID 125 mg /5 mL GFS Manufactured for |The Cathay Drug Co, Ine, |Teoretical Yield | 4,320 bots x 50 mL. Actual Yield 4,250 bots x50 mL Lot Namber 171255 DR.Number | DRP-3604 Manufacturing Date [Dee 2016 Certificate No. | CLA-GS-125-000-16-26 Expiration Date [Dee 2018 Document No. COA-QFP-GS26 | Performed by / Date: Prepared by / Date: Maria A} ss / 11-19-16 Ella May/A, Mabaga / {2-19-16 Rog Assistant | Checked by / Date: Zenaida M. Mahglicmot / 12-19-16 -Aboratory Head ~Gatdula / 12-19-16 QA Manager Evel Page 3 of 3 page/s Tel. No.: (049) 541-3222; Fax No.: (049) 641-3288; Cell, No.: 0927-9704037 mall: qa@el-laboratories.com108 North Main Ave., Laguna Technopark, Biftan, Laguna, Philippines 4024 SPOS es sc. CERTIFICATE OF ANALYSIS (RAW MATERIAL) ‘CLARITHROMYCIN CARBOMER COMPLEX COATED GRANULES Raw Material Code | RAC-GR-CLA-CDC | Lot Number '$62892-B Chemical Formula | CyHeNO1s ‘Quantity Delivered. 222,980 g (2739552 22. drams x 10,000 g3 Mfr, Lot No, Breakdown of Container 1 dram x 2,980. Mfg. Date’ Nov 2015 Certificate Number a RAC-GR-CLA-CDC-16-05 Expiration Date | Oct 2017 ‘Document Number COA-QRM-AS-126 Manufacturer ‘Sun Pharmaceutical Industries Ltd. Supplier ‘The Cathay Drug Company, Ine. ‘Test Requirements ‘Specifications ‘Results 1, Description White to off white granules Off-white granules 2, Identification The retention times ofthe major peaks for inthe Conforms chromatogram of the assay preparation to the standard | ‘as obtained in the assay. ‘ 3. Loss on Drying ‘Not more than 5.0% 45% 4. Dissolution Test 4:1 Buffer Dissolution | Not less than 80% of the assayed amount of 93.9% Clarithromycin is dissolved in 60 minutes. 4.2 Acid Resistance ‘Not more than 10% of Clatithromycin is released in 0.0% 60'minutes. 5. Assay Not less than 38.0% calculated on as is basis. 9% Reference Method Transfer Action: RELEASED. Page 1 of 2 page/s “Tel. No: (949) 841-3222; Fax No: (040) 641-2208 Emo gageleborstones.comRAT QRS, se. 108 North Mein Ave., Laguna Technopark, Bilan, Laguna, Piippines #024 CERTIFICATE OF ANALYSIS. (RAW MATERIAL) CLARITHROMYCIN CARBOMER COMPLEX COATED GRANULES Raw Material Code -| RAC-GR-CLA-CDC | Lot Number tT $62892-B. Chemical Formula | CsgHeNOs ‘Quantity Delivered 222,980 5 = 5 22 drums x 10,000 gs Mf. Lot No, 2739552 Breakdown of Container ‘Ldram x 2,980 ¢ Mfg. Date Nov 2015 Certificate Number | RAC-GR-CLA-CDC-16-05 Expiration Date | Oct 2017 ‘Document Number ‘COA-QRM-AS-126 ‘Manufacturer ‘Sun Pharmaceutical Industries Ltd, ‘Supplier ‘The Cathay Drag Company, Inc. Performed by / Date: Checked by / Date: 0 / 08-08-16 J 10-17-16 QA. 98-08-16. Approved by /D yet Prepared by / Date: Jessica L. fatal / 10-17-16 Re-evaluation Set ‘QA Sénior Analyst “Tel: No (040) 541 -s222; Fax No. (046) 841-2288 ‘E-mail ie aboratries.com Page 2 of 2 page’s