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:112488

品名:N-Acetyl-DL-tryptophan suitable for biopharmaceutical production EMPROVE® bio Ph Eur,BP

中文名:N-乙酰-DL-色氨酸

内毒素:50 I.U./g

 

N- 乙酰-DL- 色氨酸 N-Acetyl-DL-tryptophan 112488
规格
Assay (alkalimetric, calculated on dried substance) 99.0 - 101.0 %
Identity (IR-spectrum) passes test
Appearance white to almost white, crystalline powder or colorless crystals
Appearance of solution (10 g/l; sodium hydroxide solution 1 mol/l) clear and not more intense in color than reference solution Y₇ or GY₇
Opt. rotation (100 g/l, sodium hydroxide 1 mol/l) -0.1 to +0.1
Fe (Iron) ≤ 10 ppm
NH₄ (Ammonium) ≤ 200 ppm
Residual solvents (ICH Q3C) excluded by manufacturing process
Related substances (HPLC) (largest single impurity) ≤ 0.25 %
Related substances (HPLC) (Sum of all impurities) ≤ 0.5 %
Sulfated ash (600 °C) ≤ 0.1 %
Loss on Drying (105°C) ≤ 0.5 %
Bacterial endotoxins ≤ 50 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