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:141355

品名:Polyvinyl alcohol 18-88 suitable for use as excipient EMPROVE® Essential Ph Eur,USP,JPE

中文名:聚乙烯醇18-88

内毒素:0.03 I.U./mg

TAMC(总菌):1x10²CFU/g

 

TYMC(霉菌/酵母):1x10²CFU/g

 聚乙烯醇18-88 Polyvinyl alcohol 141355
规格
Identity (IR spectrum) passes test
Identity (Viscosity) passes test
Identity (Reaction with iodine) passes test
Identity (Reaction with iodine and boric acid) passes test
Identity (Reaction with ethanol) passes test
Appearance of solution (40 g/l, water) passes test
Appearance of solution (50 g/l, water) passes test
Water-insoluble matter (40 g/l, water) ≤ 0.1 %
pH-Value (40 g/l; water) 5.0 - 6.5
Viscosity (40 g/l; water) 15.3 - 20.7 mPa∙s
As (Arsenic) ≤ 2 ppm
Heavy metals (as Pb) ≤ 10 ppm
Crotonaldehyde (GC) ≤ 10 ppm
Acetic acid (alkalimetric) ≤ 0.5 %
Methanol (GC) ≤ 1.0 %
Methyl acetate (GC) ≤ 1.0 %
Other residual solvents (ICH Q3C) ...excluded by production process
Ester value 130 - 150
Degree of hydrolysis (USP) 85 - 89 %
Degree of hydrolysis (JPE) 78 - 96 %
Acid value ≤ 3.0
Saponification value 132 - 152
Sulfated ash ≤ 1.0 %
Loss on Drying (105°C) ≤ 5.0 %
Endotoxins ≤ 0.03 I.U./mg
Microbiological purity (Total aerobic microbial count (TAMC)) ≤ 100 CFU/g
Microbiological purity (Total yeast and mould count (TYMC)) ≤ 100 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g) conforms
Escherichia coli (absent in 1 g) conforms
Pseudomonas aeruginosa (absent in 1 g) conforms
Staphylococcus aureus (absent in 1 g) conforms
Candida albicans (absent in 1 g) conforms
Salmonella (absent in 10 g) conforms
Residues of metal catalysts or metal reagents acc. to EMEA/C HMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph Eur,USP,JPE