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:100320

品名:Potassium Chloride suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,JP,USP,E 508,FCC

中文名:氯化钾(JXFL1200031国)

内毒素:5.0 I.U./g

 

氯化钾(JXFL1200031国)Potassium chloride 100320
规格
Assay (argentometric; calculated on dried substance) 99.0 - 100.5 %
Assay (argentometric; dried substance) 99.0 - 101.0 %
Identity passes test
Appearance of solution passes test
In water insoluble matter ≤ 0.01 %
pH-value (5 %; water) 5.3 - 8.0
Free acid, free alkali passes test
Acidity or alkalinity passes test
Bromide (Br)
passes test
  ≤ 0.1 %
Iodide (I) ≤ 0.005 %
Bromide, Iodide (Br,I) passes test
Phosphate (PO₄) ≤ 0.0005 %
Sulphate (SO₄) ≤ 0.01 %
Total nitrogen (N) ≤ 0.001 %
Heavy metals (as Pb) ≤ 0.0005 %
Al (Aluminium) ≤ 0.00010 %
As (Arsenic) ≤ 0.0001 %
Ba (Barium) passes test
Cd (Cadmium) ≤ 0.0001 %
Cu (Copper) ≤ 0.0002 %
Fe (Iron) ≤ 0.001 %
Hg (Mercury) ≤ 0.0001 %
Na (Sodium) ≤ 0.05 %
Na (sodium) passes test
Pb (Lead) ≤ 0.0002 %
Zn (Zinc) ≤ 0.0025 %
Ca + Mg (calcium and magnesium) passes test
Magnesium and alkaline-earth metals (as Ca) ≤ 0.02 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Loss on drying (130 °C) ≤ 0.5 %
Endotoxins ≤ 5.0 I.U./g
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph Eur, BP, JP, USP, E 508, FCC
Conforms to the purity criteria on food additives according to the current European Commission Regulation.