/_»_ ALCON BIOSCIENCES PRIVATE LIMITED 104, Phase Il, GIDC-Vapi, Gujarat-396 196, India +91(0260) 2401585 + Fax: +91 (0260) 2433964 QUALITY ASSURANCE DEPARTMENT CERTIFICATE OF ANALYSIS Product ISACODYL BP Batch No LC/BSD/170101 AR.No : BSD/JAN/I70101 Batch Size Sampled on 14/01/2017 Mfg. Date Sample Qty : 2x25 gms Exp. Date Release Date : 20/01/2017 RESULTS OF ANALYSIS: TEST SPECIFICATION RESULTS | DESCRIPTION White or almost white, crystalline powder. A white, crystalline powder. SOLUBILITY Practically insoluble in water, soluble in Practically insoluble in water, acetone, sparingly soluble in ethanol (96 %). | soluble in acetone, sparingly It dissolves in dilute mineral acids. soluble in ethanol (96 %). It dissolves in dilute mineral acids. IDENTIFICATION | ©) IR Spectrum: Should be concordant with | C) IR Spectrum: Concordant working standard. with working standard, ACIDITY OR Not more than 0.40 mi of 0.01 M 0.30 ml of 0.01 M hydrochloric ALKALINITY hydrochloric acid is required to the change the | acid is required to the change the | colour of the indicator to red. colour of the solution to red. RELATED Impurity A: Not more than 0.1 % Not Detected SUBSTANCES Impurity B : Not more than 0.1 % Not Detected (By HPLC) Impurity C : Not more than 0.5 % 022% Impurity D : Not more than 0.2 % Not Detected Impurity E : Not more than 0.5 % 0.12% Impurity F : Not more than 0.3 % Not Detected Unspecified impurity : Not more than 0.10% | Not Detected Total impurities : Not more than 1.0 % 034 % LOSS ON DRYING __| Not more than 0.5 % wiw 0.38%, SULPHATED ASH __| Not more than 0.1 % wiw 0.04 % ‘ASSAY (By Not less than 98.00 % and not more than 99.65% Potentiometric 101.00 % (Calculated on dried basis) Titration) OPINION: In the opinion of the undersigned, the above mentioned sample is of STANDARD QUALITY. The above mentioned sample COMPLIES with prescribed specification as per BP 2013. Prepared By Verified By proved By Ryo — Mr. Ajeet singh ‘Mr.Ramesh pandey Mr-.Sureshhsingh Officer QC Executive QC Manager QA & QC ‘Admn. Office: 112, Marine Chambers, 1¥ New Marne Lines, Mumbai -400 020, india, Tel: ++91-22-6533 2427-31 Fax : +491-22-2207 1965 + E-mail : mitg@alconpherma com + Web Site - www alconpharma.com