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:100971

品名:Ethanol 96% suitable for use as excipient EMPROVE® Essential Ph Eur,BP

中文名:乙醇(96%

内毒素:2.5 I.U./ml

TAMC(总菌):100 CFU/g

 

TYMC(霉菌/酵母):10 CFU/g

乙醇(96%)Ethanol 100971
规格
Assay (m/m) 92.6 - 95.2 %
Assay (V/V) 95.1 - 96.9 %
Identity (IR) conforms
Appearance conforms
Acidity or alkalinity ≤ 30 ppm
Density (d 20 °C/20 °C) 0.805 - 0.812
Absorbance (at 240 nm) ≤ 0.40
Absorbance (between 250nm and 260nm) ≤ 0.30
Absorbance (between 270nm and 340nm) ≤ 0.10
The spectrum shows a steadily descending curve with no observable peaks or shoulders conforms
Volatile impurities (GC) (Acetaldehyde and Acetal) ≤ 10 ppm
Volatile impurities (GC) (Benzene) ≤ 2 ppm
Volatile impurities (GC) (Methanol) ≤ 200 ppm
Volatile impurities (GC) (Total of other impurities) ≤ 300 ppm
Volatile impurities (GC) (disregard limit) ≤ 9 ppm
Other residual solvents (ICH Q3C) excluded by production process
Evaporation residue ≤ 25 mg/l
Bacterial endotoxins ≤ 2.5
Total aerobic microbial count (TAMC) ≤ 100
Total combined yeasts/moulds count (TYMC) ≤ 10
Bile-tolerant gram-negative bacteria (absent in 1 g) passes test
Candida albicans (absent in 1 g) passes test
Escherichia coli (absent in 1 g) passes test
Pseudomonas aeruginosa (absent in 1 g) passes test
Salmonella (absent in 10 g) passes test
Staphylococcus aureus (absent in 1 g) passes test
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Conforms to Ph Eur, BP