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:104352

品名:L-Histidine suitable for use as excipient EMPROVE® EssentialPh Eur,US

中文名:葡萄糖(一水)

内毒素:组氨酸

TAMC(总菌):2.0 I.U./g

 

组氨酸 Histidine 104532
规格
Assay (acidimetric, calculated on dried substance) 98.5 - 101.0 %
Assay (perchloric acid titration, calculated on dried substance) 99.0 - 101.0 %
Identity (IR-spectrum) passes test
Appearance white to almost white fine-crystalline powder or colorless crystals
Appearance of solution (50 g/l; water) clear and not more intense in color than reference solution BY₇.
Appearance of solution (20 g/l, water) clear and colorless
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance) +11.4 to +12.4
Spec. rotation (α 25/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) +12.6 to +14.0
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) +11,8° to +12,8°
pH (20 g/l, CO₂-free water) 7.0 - 8.5
Chloride (Cl) ≤ 200 ppm
Sulphate (SO₄) ≤ 200 ppm
Heavy metals (as Pb) ≤ 10 ppm
Fe (Iron) ≤ 10 ppm
Related Compounds, total (TLC) ≤ 0.5 %
Related substances (TLC) passes test
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) ≤ 0.2 %
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
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000
are not likely to be present.
Corresponds to Ph. Eur., JP, USP