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:137000

品名:Acetic acidglacial100% suitable for biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP,ACS

中文名:冰醋酸

内毒素:2.5 I.U./ml

 

冰醋酸 Acetic acid (glacial) 137000
规格
Assay (alkalimetric) 99.8 - 100.5 %
Identity passes test
Colour (Hazen) ≤ 10 Hazen
Appearance of the substance passes test
Formic acid, Formates and other oxidable impurities (as HCOOH) ≤ 0.5 %
Titratable base ≤ 0.0004 meq/g
Solidification temperature ≥ 16.3 °C
Chloride (Cl) ≤ 2 ppm
Sulphate (SO₄) ≤ 5 ppm
Heavy metals (as Pb) ≤ 5 ppm
Fe (Iron) ≤ 0.2 ppm
Other residual solvents (ICH Q3C) ...excluded by production process
Reducing substances (Ph Eur) passes test
Substances reducing potassium permanganate passes test
Evaporation residue ≤ 50 ppm
Dilution test passes test
Endotoxins ≤ 2.5 I.U./ml

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 (*).