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:101544

品名:L-Arginine monohydrochloride suitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP

中文名:精氨酸盐酸盐

内毒素:3.0 I.U./g

 

精氨酸盐酸盐 Arginine monohydrochloride 101544
规格
Assay (perchloric acid titration, calculated on dried substance) 98.5 - 101.0 %
Identity (IR-spectrum) passes test
Identity (Chloride) passes test
Appearance white to almost white or colorless, irregular crystals
Appearance of solution (50 g/l; water) clear and not more intense in color than reference solution BY₆
Appearance of solution (100 g/l, water) clear and colorless
pH (100 g/l, CO₂-free water) 4.7 - 6.2
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) +21.0 to +23.5
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) +21.4 to +23.6
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance) +21,5 to +23,5
Chloride (Cl) (argentometric) 16.5 - 17.1 %
Sulphate (SO₄) ≤ 200 ppm
Heavy metals (as Pb) ≤ 10 ppm
As (Arsenic) ≤ 2 ppm
Fe (Iron) ≤ 10 ppm
NH₄ (Ammonium) ≤ 200 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, 2 h) ≤ 0.2 %
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.