规格
Assay (complexometric) 99.0 - 101.0 %
Identity passes test
Appearance of solution passes test
Insoluble matter ≤ 0.005 %
Acidity or alkalinity passes test
pH-value (5 %; water) 5.0 - 7.0
Bromide (Br) ≤ 0.05 %
Sulphate (SO₄) ≤ 0.005 %
Heavy metals (as Pb) ≤ 0.001 %
Al (Aluminium) ≤ 0.0001 %
As (Arsenic) ≤ 0.0002 %
Ba (Barium) passes test
Ca (Calcium) ≤ 0.01 %
Fe (Iron) ≤ 0.0005 %
Hg (Mercury) ≤ 0.0001 %
K (Potassium) ≤ 0.0500 %
NH₄ (Ammonium) ≤ 0.005 %
Pb (Lead) ≤ 0.0002 %
Residual solvents (Ph.Eur./USP/ICH) excluded by manufacturing process
Water 51.0 - 55.0 %
Endotoxins ≤ 3.0 I.U./g
Total aerobic microbial count ≤ 100 CFU/g
Total yeast and mould count ≤ 100 CFU/g
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph Eur, BP, USP, JPC, FCC, E511
氯化镁(六水,结晶,JXFL1200032 国)Magnesium chloride hexahydrate 105832

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:105832

品名:Magnesium chloride hexahydrate cryst. EMPROVE® Ph Eur,BP,USP,JPC,FCC,E 511

中文名:氯化镁(六水,结晶,JXFL1200032 国)

内毒素:3.0 I.U./g

TAMC(总菌):100 CFU/g

 

TYMC(霉菌/酵母):100 CFU/g