Batch-no, Re-evaluation date: Manufacturing date JRS PHARMA IRS) The exciprent roma ww eile EXPLOTAB® CLV Sodium Starch Glycolate, Type A Ph. Eur., NF, JP CERTIFICATE OF ANALYSIS 4111022077 06 / 2016 06 / 2012 Manufacturing site: Pirna, Germany * Results reported are expected results based on periodic testing ‘The batch described by this certificate meets the requirements of Ph. Eur., NF, JP and JPE monographs for ‘Sodium Starch Glycolate” current edition. Its released on the basis of the results ascertained, The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur.<5.4>, USP<467>) except for Ethanol limited to < 3.0%, Note: Any microbial results stated in above are established from the commercial lot. This sample is not intended for microbial testing and is not for human consumption ‘Almost white, fine, free-flowing powder, very hygroscopic, practically insoluble in Description ‘methylene chloride. It gives a translucent suspension in water | Examined under a microscope it conforms to the description of Ph. Eur. | a Produced from potato starch with a cross-linking agent. J Standards Specification Batch Result Reference | Settling volume: 16 — 38 mi/g 21 mig T CMS 024 (CHP) | Viscosity max. 40 mPas 9mPas T CMS 053 (CHP) | | Particle size [through 140 mesh (108 um)] min. 99 % passes* T226F (MCW) Sulfated ash max. 15.0 % passes‘ T CMS 047 (CHP) {Pharmacopoeial test items Specification Batch Result Reference [Identification (NF A, B, C, D) passes passes” NF Identification (Ph. Eur. A) passes passes Ph. Eur. Identification (Ph. Eur. B, C, D) passes passes” Ph, Eur. Identification JP (1, 2, 3) passes passes” JP | pH 65-75 64 Ph. Eur., NF, JP | Loss on drying max. 10.0 % 7.0% Ph. Eur., NF, JP Assay (Na’ from Starch glycolate) 2.8-4.2% 3.1% Ph. Eur., NF, JP ‘Sodium chloride max. 7.0% 3.5% T CMS 012 (CHP) Residue of Ethanol max. 3.0% < 3.0% T CMS 054 (CHP) Appearance of solution passes passes” Ph. Eur. Sodium glycolate max. 2.0 % < 2.0%" Ph. Eur, NF, JP Heavy metals max, 20 ppm <20ppm* —T CMS 043 (CHP) Iron max. 20 ppm <20ppm* — T CMS 043 (CHP) Total aerobic microbial count (TAMC) — max.1000 CFU/g < 1000 CFU/g* Ph. Eur., USP Total yeasts and molds count (TYMC) max. 100CFU/g < 100 CFU/g* Ph. Eur., USP E. coli, Pseudomonas aeruginosa absent in 10g absent * Ph. Eur., USP |Staph. aureus, Salmonella spec. absent in 109 absent * use ‘Storage recommendation: Protect from excessive heat and moisture. Keep containers closed. July 19, 2012 Ref, EXPCLY POS JRS PHARMA cusi « co. Ke MEE + 49 oy 07 152512 Mathias Winkelmann QUALITY CONTROL CHP Carbohydrate Pirna usa + canta JRS PHARMA LP reat 145) 878 3488