D(+)-Glucosio monoidrato, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
(2S,3R,4S,5S,6R)-6-(Hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol hydrate, Dextrose monohydrate
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certificazioni: corresponds to Ph Eur, BP, USP
Formula:
C₆H₁₂O₆·H₂O Peso molecolare: 198,17 g/mol Punto di fusione: 83 °C Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00149450 CAS Number: 14431-43-7 EINECS: 200-075-1 |
Risultati del test di specificazione
Assay (calc. on anhydrous substance) | 97.5 - 102.0 % |
Identity (IR) | passes test |
Identity (spec. rotation calc. on anhydrous substance) | passes test |
Identity (HPLC) | passes test |
Identity (water) | passes test |
Appearance of solution | passes test |
Color and clarity of solution | passes test |
Conductivity | ≤ 20 µS/cm |
Heavy metals (as Pb) | ≤ 5 ppm |
Cu (Copper) | ≤ 0.0025 % |
Zn (Zinc) | ≤ 0.0025 % |
Related substances [sum of impurities A (maltose) and B (isomaltose)! | ≤ 0.4 % |
Related substances [Impurity C (maltotriose)! | ≤ 0.2 % |
Related substances [Impurity D (fructose)! | ≤ 0.15 % |
Related substances (unspecified impurities) | ≤ 0.10 % |
Related substances (Sum of all impurities) | ≤ 0.5 % |
Dextrin | passes test |
Soluble starch, sulfite | ≤ 15 ppm |
Residual solvents (ICH Q3C) | excluded by manucaturing process |
Water (according to Karl Fischer) | 7.5 - 9.5 % |
Endotoxins | ≤ 2.5 I.U./g |
Microbiological purity (Total aerobic microbial count (TAMC)) | ≤ 1000 CFU/g |
Microbiological purity (Total yeast and mould count (TYMC)) | ≤ 100 CFU/g |
Bile tolerant Gram negative Bacteria (absent in 1 g) | passes test |
Escherichia coli (absent in 1 g) | passes test |
Pseudomonas aeruginosa (absent in 1 g) | passes test |
Staphylococcus aureus (absent in 1 g) | passes test |
Candida albicans (absent in 1 g) | passes test |
Salmonella ssp (absent in 10 g) | passes test |
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