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:105303

品名:D--Mannitol low in endotoxins, suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,USP,JP

中文名:甘露醇(低内毒素,原料药级,JXHL1300010 , DMF

内毒素:1 I.U./g

TAMC(总菌):200 CFU/g

 

TYMC(霉菌/酵母):100 CFU/g

甘露醇(低内毒素,原料药级,JXHL1300010国,DMF)Mannitol 105303
规格
Assay (HPLC, calc. on dried substance) 98.0 - 101.0 %
Identity (IR-spectrum) passes test
Appearance of solution (10 %; water) passes test
pH-value (10 %; water) 4.5 - 7.5
Melting point 165 - 169
Conductivity (25°C) (20 %; water) ≤ 20
Heavy metals (as Pb) ≤ 0.0005 %
Ni (Nickel) ≤ 0.0001 %
Pb (Lead) ≤ 0.00005 %
Related substances (HPLC) (Sorbitol (Impurity A)) ≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)) ≤ 2.0
Related substances (HPLC) (Major unspecified impurity) ≤ 0.10 %
Related substances (HPLC) (Sum of all impurities) ≤ 2.0 %
Reducing sugars (as glucose) ≤ 0.05
Reducing sugars after hydrolysis/total sugar (as glucose) ≤ 1
Sulfated ash ≤ 0.1
Water ≤ 0.5
Loss on Drying (105°C) ≤ 0.30 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Microbiological test passes test
Colony count (aerobic bacteria (TAMC)) ≤ 10²
Colony count (Yeasts and moulds (TYMC)) ≤ 10²
Salmonella species In 10g substance not detectable
E.coli In 1g substance not detectable
Staphylococcus aureus In 1g substance not detectable
Pseudomonas aeruginosa In 1g substance not detectable
Candida albicans In 1g substance not detectable
Endotoxins (kinetic turbidimetric test) ≤ 1
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph. Eur., BP, USP, JP