JRS PHARMA JIRS) BRR EMDEX® NON GMO Dextates, Hydrated, NF CERTIFICATE OF ANALYSIS. Batch No, ENB20G30H ltem No. EMDEX-N-GMO-US-A5005 Re-evaluation date: 31-Jul-2023 Manufacturing site: 725 41st Ave DR SW Manufacturing dato: 31-Jul-2020 Cedar Rapids, 1A., USA Characteristics Acceptance crit Batch result Reference Dextrose equivalent 93.0 - 99.0% 97.3 % NE Heavy metals Max. 5 ppm <5 ppm IRS Pharma Method Loss on drying 78-92% 85 % use oH 38-58 53 usp Residval solvents Meets requirement Conforms USP Residus on ignition Max.0.1% <01 % usP Sulfur dioxide Max.10 ppm <10 ppm USP Total aerobic microbial count 10? efurg < 10 cfulg USP Escherichia col Absent in 1 g Absent usP* Salmonella species Absent in 10.9 Absent use* Particle size (Ro-Tap) IRS Pharma Method >850 ym (20 mesh) Max. 3% 02 % <150 um (100 mesh) Mex: 25% an Tapped density 0.68 - 0.89 gimL 0.78 gimL JS Pharma Method RS Pharma requirement. Not included in the dextrates monograph. Performed per USP <6t> and USP <62> eM NON GMO is manufactured under GMP for excipients according to IPEC and USP <10785, The raw material, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (USP <467>, Ph Eur, <6.4>). Elements lstad in ICH Q30 Guideline for elemental impurities are not used in manufacturing and not anelyzed per batch, detailed information is available upon request. EMDEX" is a registered trademark of J. Rettenmaiar & Séhne GmbH + Co. KG. Bugues 14, 2050 dato (CONEmdentenS¥sONew_01 orawide reccquarters JRS PHARMA cui a co. xe 13404 Raseteg (Gorrany) Prone: 443.0 1957/1900 Foe" éo Wo re6r/ 462 265 Inbar reer de ws SUELAETSISUM + 49 (0) 7067 / 252 942 QUALITY ASSURANCE, JRS PHARMA LP o1aug 16 Page 1 of USA + conga JRS PHARMA LP 2903 Rout 22, Sute 4 Patesan, NY 12568-2959, USA Toto (SA #1 eGo} 42407 Phones 1 (as) 678324» Foc + 1 845) 78 304 +Tieash ere 383s