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:100590

品名:Glycine cryst. suitable for use as excipient EMPROVE® Essential Ph.Eur.,BP,JP,USP

中文名:甘氨酸

内毒素:3.0 I.U./g

 

甘氨酸 Glycine cryst 100590
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
Appearance of solution (100 g/l, CO₂-free water) clear and colorless and not more intense in color than reference solution Y₇
pH (50 g/l CO₂-free water) 5.9 - 6.4
Chloride (Cl) ≤ 70 ppm
Sulphate (SO₄) ≤ 65 ppm
Heavy metals (as Pb) ≤ 10 ppm
As (Arsenic) ≤ 2 ppm
Hydrolyzable substances passes test
Related substances (TLC) passes test
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) ≤ 0.10 %
Ninhydrin-positive substances (LC) (ammonium (570 nm)) ≤ 0.02 %
Ninhydrin-positive substances (LC) (total impurities) ≤ 1.0 %
Related substances (HPLC) (Impurity B) ≤ 0.10 %
Related substances (HPLC) (Impurity H) ≤ 0.10 %
Related substances (HPLC) (Impurity I) ≤ 0.10 %
Related substances (HPLC) (unspecified impurities) ≤ 0.10 %
Related substances (HPLC) (Sum of all impurities) ≤ 0.2 %
Methanol (HS-GC) ≤ 3000 ppm
Other residual solvents (ICH Q3C) excluded by manufacturing process
Loss on drying (105 °C, 2 h) ≤ 0.2 %
Sulfated ash (600 °C) ≤ 0.1 %
Bacterial endotoxins ≤ 3.0 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., BP, JP, USP