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  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:106143
品名:Meglumine low in endotoxins suitable for use as active pharmaceutical ingredient EMPROVE® api Ph Eur,JP,USP
中文名:葡甲胺(低内毒素,原料药级, JXHL1300504,DMF
内毒素:LAL-test1.5 U./g
 

 

 

 

 

 

葡甲胺(低内毒素,原料药级, JXHL1300504国,DMF)Meglumine 106143
规格
Assay (acidimetric; calculated on dried substance) 99.0 - 100.5 %
Identity IR spectrum conforms
Melting point 128 - 131
Spec. rotation (α 20/D; 10 %; water; calculated on dried substance) -17.0 - -16.0 °
Absorbance of solution (5 cm; 30 % m/V; water) (at 350 nm) ≤ 0.200
Absorbance of solution (5 cm; 30 % m/V; water) (at 400 nm) ≤ 0.100
Absorbance of solution (5 cm; 30 % m/V; water) (at 450 nm) ≤ 0.080
Absorbance of solution (1 cm; 30 % m/V; water) (at 420 nm) ≤ 0.045
Absorbance of solution (1 cm; 30 % m/V; water) (at 555 nm) ≤ 0.050
Appearance of solution (30 % m/v; water) clear
Chloride (Cl) ≤ 0.009 %
Cyanide (CN) ≤ 0.0002 %
Sulphate (SO₄) ≤ 0.015 %
Heavy metals (as Pb) ≤ 0.001 %
As (Arsenic) ≤ 0.0001 %
Al (Aluminium) ≤ 0.0005 %
Ni (Nickel) (#) ≤ 0.0005 %
Fe (Iron) ≤ 0.001 %
Reducing matter ≤ 0.2 %
Sulfated ash ≤ 0.10 %
Loss on Drying (105°C) ≤ 0.2
Other residual solvents (Ph.Eur./ICH) excluded by the manufacturing process
Bacterial endotoxins test (LAL-test) ≤ 1.5 I.U./g
Methanol (GC) ≤ 0.2 %
Corresponds to Ph.Eur, JP, USP
# specified acc. to EMEA/CHMP/SWP/4446/2000 (Specification limits for residues of metal catalysts or metal reagents). Other residues of metal catalysts or metal reagents acc. to this guideline are not likely to be present.