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  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:105829

品名:Magnesium hydroxide carbonate heavy extra pure Ph Eur,BP,USP,E 504

中文名:碳酸氢氧镁(重质)

TAMC(总菌):2000 CFU/g

 

TYMC(霉菌/酵母):200 CFU/g

碳酸氢氧镁(重质)Magnesium hydroxide carbonate 105829
规格
Assay (complexometric calculated as Magnesiumoxide) 40.0 - 43.5 %
Assay USP (calculated as Magnesiumoxide) 40.0 - 43.5 %
Identity passes test
Appearance of solution passes test
Substances soluble in water ≤ 1.0 %
soluble salts ≤ 1.0 %
Substances insoluble in acetic acid ≤ 0.05 %
Substances insoluble in acid ≤ 0.05 %
Chloride (Cl) ≤ 0.02 %
Sulfate (SO₄) ≤ 0.3 %
Heavy metals (as Pb) ≤ 0.001 %
As (Arsenic) ≤ 0.0002 %
Ca (Calcium) ≤ 0.4 %
Fe (Iron) ≤ 0.005 %
Hg (Mercury) ≤ 0.0001 %
Na (Sodium) ≤ 0.1 %
Ni (Nickel)* ≤ 0.0100 %
Pb (Lead) ≤ 0.0002 %
Si (Silicon) ≤ 0.05 %
V (Vanadium)* ≤ 0.0010 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Bulk density ≥ 0.25 g/ml
Total aerobic microbial count ≤ 2000 CFU/g
Total yeast and mould count ≤ 200 CFU/g
E.coli (absent in 1 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, E 504
Conforms to the purity criteria on food additives according to the current European Commission Regulation.