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:102304

品名:Calcium hydrogen phosphate anhydrous extra fine powder suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,FCC,E 341

中文名:无水磷酸氢钙JXFL1200033 国)

TAMC(总菌):2000 CFU/g

 

TYMC(霉菌/酵母):200 CFU/g

无水磷酸氢钙 (JXFL1200033 国)Calcium hydrogen phosphate 102304
规格
Assay (complexometric) 98.0 - 103.0 %
Assay (complexometric; calculated on dried substance) 98.0 - 102.0 %
Identity passes test
Substances insoluble in hydrochloric acid ≤ 0.2 %
Carbonate (as CO₂) passes test
Chloride (Cl) ≤ 0.03 %
Fluoride (F) ≤ 0.005 %
Sulphate (SO₄) ≤ 0.48 %
Heavy metals (as Pb) ≤ 0.001 %
Al (Aluminium) < 0.0100
As (Arsenic) ≤ 0.0001 %
Ba (Barium) passes test
Cd (Cadmium) ≤ 0.0001 %
Cr (Chromium) ≤ 0.0005 %
Fe (Iron) ≤ 0.04 %
Hg (Mercury) ≤ 0.0001 %
Mg (Magnesium) ≤ 0.5 %
Mn (Manganese) ≤ 0.03 %
Na (Sodium) ≤ 0.05 %
Pb (Lead) ≤ 0.0001 %
Sr (Strontium) ≤ 0.03 %
V (Vanadium) ≤ 0.0003 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Loss on ignition (800 °C) 7.0 - 8.5 %
Loss on drying ≤ 2.0 %
Particle Size (d90) ≤ 130 µm
Particle Size (d50) ≤ 70 µm
Total aerobic microbial count ≤ 2000 CFU/g
Total yeast and mould count ≤ 200 CFU/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, FCC, E 341
Conforms to the purity criteria on food additives according to the current European Commission Regulation.