默克药用低内毒素系列产品的生产工艺、生产环境、包装系统均严格符合高风险制剂的生产和研发要求。该系列产品以极低的内毒素/微生物控制水平以及全球领先的杂质控制技术大大降低了除菌工艺的风险和确保了制剂的长期稳定性。EMPROVE®文件系统,参考 ICH Q9 和 EU 2015/C95/02 提供风险评估支持,为国际化产品提供法规助力。 

货号:108346

品名:D+-Glucose monohydrate suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP

中文名:葡萄糖(一水)

内毒素:2.5 I.U./g

TAMC(总菌):1000 CFU/g

 

TYMC(霉菌/酵母):100 CFU/g

葡萄糖(一水)Glucose monohydrate 108346
规格
Assay (calc. on anhydrous substance) 97.5 - 102.0 %
Identity passes test
Appearance of solution passes test
Colour 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
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 (*).
corresponds to Ph Eur, BP, USP