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:100242

品名:Citric acid monohydrate cryst., suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 330,FCC

中文名:柠檬酸(一水,晶体,JXFL1300021 国)

内毒素:0.5 I.U./mg

 

柠檬酸(一水,晶体,JXFL1300021 国)Citric acid monohydrate 100242
规格
Assay (alkalimetric, calculated on anhydrous substance) 99.5 - 100.5 %
Identity (IR-spectrum) passes test
Appearance white to almost white or colorless crystals
Appearance of solution (200 g/l; water) clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
Sulphate (SO₄) ≤ 50 ppm
Heavy metals (as Pb) ≤ 5 ppm
Al (Aluminium) ≤ 0.2 ppm
As (Arsenic) ≤ 1 ppm
Hg (Mercury) ≤ 1 ppm
Pb (Lead) ≤ 0.5 ppm
Oxalates (as C₂H₂O₄) ≤ 100 ppm
Residual solvents (ICH (Q3C)) excluded by manufacturing process
Readily carbonisable substance passes test
Sulfated ash (600 °C) ≤ 0.05 %
Water (according to Karl Fischer) 7.5 - 8.8 %
Bacterial endotoxins < 0.5
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, JP, USP, E 330, FCC
Conforms to the purity criteria on food additives according to the current European Commission Regulation.