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:100987

品名:Benzyl alcohol special gradebenzaldehyde <= 0.05%suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF

中文名:苯甲醇(苯甲醛_ 0.05%

内毒素:2.5 I.U./ml

TAMC(总菌):100 CFU/g

 

TYMC(霉菌/酵母):10 CFU/g

苯甲醇(苯甲醛_ 0.05%)Benzyl alcohol 100987
规格
Assay (GC) 98.0 - 100.5 %
Identity (IR) conforms
Appearance of solution (nephelometric) conforms
Clarity of solution conforms
Colour of solution conforms
Acidity conforms
Refractive index (n 20/D) 1.538 - 1.541
Density (d 20 °C/20 °C) 1.043 - 1.049
Peroxide value ≤ 5.0
Related substances (GC) (Benzaldehyde (Impurity A)) ≤ 0.05 %
Related substances (GC) (Cyclohexylmethanol (Impurity B)) ≤ 0.10 %
Related substances (GC) (Sum of peaks with a relative retention less than that of benzyl alcohol) ≤ 0.02 %
Related substances (GC) (Sum of peaks with a relative retention greater than that of benzyl alcohol) ≤ 0.20 %
Related substances (GC) (disregard limit) ≤ 0.0001 %
Benzene (GC) ≤ 0.0002 %
Chlorobenzene (GC) ≤ 0.01 %
Toluene (GC) ≤ 0.01 %
Other residual solvents (ICH Q3C) excluded by manufacturing process
Evaporation residue ≤ 0.050 %
Water ≤ 0.1 %
Bacterial endotoxins ≤ 2.5 I.U./ml
Total aerobic microbial count (TAMC) ≤ 100 CFU/g
Total combined yeasts/moulds count (TYMC) ≤ 10 CFU/g
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, JP, NF