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:112635

品名:Parteck® Delta M Mannitolsuitable for use as excipient EMPROVE® Essential Ph Eur,BP,USP,JP,E 421

中文名:Parteck® Delta 甘露醇JXFL1300013 国)

TAMC(总菌):2000 CFU/g

 

TYMC(霉菌/酵母):200 CFU/g

甘露醇 (JXFL1300013 国)Parteck® Delta M (Mannitol) 112635
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) ≤ 5 ppm
Ni (Nickel) ≤ 1 ppm
Pb (Lead) ≤ 0.5 ppm
Ru (Ruthenium) (#) ≤ 1 ppm
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)) ≤ 10³
Colony count (Yeasts and moulds (TYMC)) ≤ 10²
Salmonella spp. 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
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, USP, JP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
1) Parameter subject to statistical testing 

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, JP, USP, E 421 
This item conforms to the purity criteria on food additives according to the European Commision directive 2008/84/EG