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 (50 g/l; water) clear and not more intense in color than reference solution BY₆
Appearance of solution (100 g/l, CO₂-free water) clear and colorless
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) +25.5 to +28.5
Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) +26.3 to +27.7
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance) +26.9 to +27.9
pH (100 g/l, CO₂-free water) 10.5 - 12.0
Chloride (Cl) ≤ 200 ppm
Sulphate (SO₄) ≤ 200 ppm
Heavy metals (as Pb) ≤ 10 ppm
Fe (Iron) ≤ 10 ppm
Related Compounds, total (TLC) ≤ 0.5 %
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) ≤ 0.30 %
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.
精氨酸(JXFL100024国)L-Arginine 101587

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:101587

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

中文名:精氨酸(JXFL1300024国)

内毒素:2.0 I.U./g