D(+)-Glucose Monohydra, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
Synonyms:
Dextrose Monohydrat
, Traubenzucker Monohydrat
1.08346.9029EA
898
CHF
1.08346.9029
1.08346.9450
D(+)-Glucose Monohydra, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
D(+)-Glucose Monohydrat
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 (*).
Zertifizierungen: corresponds to Ph Eur, BP, USP
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Formel:
C₆H₁₂O₆·H₂O MW: 198,17 g/mol Melting Pt: 83 °C Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00149450 CAS-Nummer: 14431-43-7 EINECS: 200-075-1 |
|
Spezifikation Testergebnisse
| 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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