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.
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