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:101700

品名:L-Alanine suitable for use as excipient EMPROVE® EssentialPh Eur,USP

中文名:丙氨酸

内毒素:2.0 I.U./g

 

 丙氨酸 Alanine 101700
规格
Assay (perchloric acid titration, calculated on dried substance) 98.5 - 101.0 %
Identity (IR-spectrum) passes test
Appearance white to almost white crystalline powder or colorless crystals
Appearance of solution (25 g/l, water) clear and not more intense in color than reference solution BY₆
Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 250 g/l, calc. on dried substance) +13.5 to +15.5
Spec. rotation (α 25/D, 100 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) +13.7 to +15.1
pH (50 g/l CO₂-free water) 5.5 - 7.0
Chloride (Cl) ≤ 200 ppm
Sulphate (SO₄) ≤ 300 ppm
Heavy metals (as Pb) ≤ 10 ppm
Fe (Iron) ≤ 10 ppm
Related compounds (HPLC) (maleic acid) ≤ 0.05 %
Related compounds (HPLC) (malic acid) ≤ 0.05 %
Related compounds (HPLC) (fumaric acid) ≤ 0.05 %
Related compounds (HPLC) (any unspecified impurity) ≤ 0.05 %
Related compounds (HPLC) (total unspecified impurities) ≤ 0.20 %
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) ≤ 0.1 %
Ninhydrin-positive substances (LC) (ammonium (570 nm)) ≤ 0.02 %
Ninhydrin-positive substances (LC) (total impurities) ≤ 0.5 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Sulfated ash (600 °C) ≤ 0.1 %
Loss on drying (105 °C; 3 h) ≤ 0.2 %
Bacterial endotoxins ≤ 2.0 I.U./g
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., USP.