S SUPRIYA LIFESCIENCE LTD. Creating true values that binds global elt Certificate of analysis Product = | Chlorpheniramine Maleate USP Livense No. KD-129 Batch No. | :| SLL(C/0319033 Date of Manufacturing | : | 27/02/2019 Batch Qy. | :| 1000.00kg Date of reest/Expiry | : | 26/02/2024 A.R. No, : | SLLIQC/FP/i9/0243 Date of Release 05/03/2019 No, Test Specifications Results Description | White, odorless, crystalline powder. | White erystalline powder, 2.) Solubility Freely soluble in water, soluble alcoho! and in chloroform. Conforms PH (1.0%, wiv sohutiion in 4.010 5.0 484 water) - ; 4._|A. Identification by IR The IR absorpiion spestrum should be | mncordant with ‘that of | Complies {Chlorpheniramine Maleate working | standard. [B. entfisaion by HPLC The vetontion time of the maleic acid hind chlozphenaramine peaks of the ample solution corresponds to those | Complies f the standard solution, as obtained inthe Assay test. [5 Remy ty HPLC on isla T3560 1o20 er _[ Residue on ignition (, wha) | Not more than 02 008 7._| Organic impurities by HPLC @%) | ~ Diamine analog Notmore than 02 _ Chiorphenaramine TRAET | yt moze than 0.1 compound B P _ Hl Chlorphenaramine related yo moro mano] BDL compound C iv. Chlorphenaramine nitrile | Not more than 0.1 BDL | | v. Any other unspecified | not more than 0.10 BDL | | impurity : —— vi, Total Impurities ‘Not more than 0.5 BDL QA/01 11F03-b2/effetive date 05/08/2015 Page 1 of2 Corporate Office : 207/208, Udyos Bhavan, Sonawala Read, Goregaen (East), Mumbai 400 063, Maharashtra, India Tel: #91 22 40332727 /'55942507 | Fax: +91 22 26860011 ‘CIN: US1900MH2008PLC180452 | E-mail: sunriya@suprivalifescience com | Website: www.supriyalifescience.com Foctory 1-5/2, Lote Parshuram Industial Afea, M..D.C, Tal Khed, Bist Ratnagiri, Pin: 415 722, Maharashtra, Inia, Tel: +91 2356272299 | Fox +81 2356 272178 | E-Mail: factory @sunrvalilescience.cam GOVT. RECOGNISED EXPORT HOUSES SUPRIYA LIFESCIENCE LTD. Greting tue vatucr tha binds globe healt Certificate of analysis Product = | Chlorpheniramine Maleate USP License No. 2] KD-129 Batch No. SLLICI0319033 Date of Manufacturing | : | 27/02/2019 Batch Qty, 1000.00kg, Date of eeest/Expiry |: | 26/02/2024 ALR.No || SLL/QCIFE/I9/0243 Date of Release = | 05/03/2019 S.No. Test Specifications Results ‘Optical rotation at 20°C (100 8. | mg/ml solution in water) (°) O10 tor O10: 0.001, 9. 18 @1OS°C for 3 brs. | Not more than 0.5 0.15 | 10. | Additional test: 10.1 | Residual Solvents by GC-HS (ppm) i, Methanol ‘Not more than 3000 BDL ii. sopropanol Not more than 5000 344 iii, O-Xylene ‘Not more than 2170 BDL Remarks: The product is complies with respect to above mentioned test as per USP41 specifications. Storage: Preserve in tight, light-resistant containers. er1e3 9 | efauy OSs! ‘Compiled by QC Checked by QC Appro®ed by Qt QC Chemist(MAKadu) | _QC Executive (V.8.Patil) QC Head (S.H.Kambale) QW 1/F03-02/Effetive date 05/08/2015 Page? of 2 Corporate Office Foctory Tol: +91 22 40332727 /.65942507 | Fax: #91 22 26860011 In: US1900MH2008°LC180452 | E-mail: supriva@supriyalifescience com | Website: yoww.suntiyalifescience.com 5/2, Lote Parshuram Industrial Area, M.LD.C,Tal-Khed, Dist- Ratnagitl, Pin: 418 722, Maharashtra, Inca. ‘el: +91 2356 272299 | Fax: 491 2356 272178 | E-Mail: factorw@sunrivalfescience com Govt. RECOGNISED EXPORT HOUSE 207/208, Udyog Bhavan, Sonawala Road, Goregaon (East), Mumba 400 063, Maharashtra, India.