纯化水英汉对照-欧洲药典8.0

WATER, PURIFIED

纯化水

H2O M r 18.12 DEFINITION

Water for the preparation of medicines other than those that are required to be both sterile and apyrogenic, unless otherwise justified and authorized.

定义

制药用水不同于其它用水，要求它是无菌的、无热源的，除非另有调整或授权。

Purified water in bulk

散装纯化水

PRODUCTION

Purified water in bulk is prepared by distillation, by ion exchange, by reverse osmosis or by any other suitable method from water that complies with the regulations on water intended for human consumption laid down by the competent authority. Purified water in bulk is stored and distributed in conditions designed to prevent growth of micro-organisms and to avoid any other contamination.

生产：

散装纯化水是经合格的当局规定的适宜人类使用的水经蒸馏、离子交换、反渗透膜或其他任何适合的方法制备。散装纯化水存储和分配于

可防止微生物生长和可避免其他任何污染的条件下。Microbiological monitoring During production and subsequent storage, appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored. Appropriate alert and action levels are set so as to detect adverse trends. Under normal conditions, an appropriate action level is a microbial count of 100 CFU/mL, determined by filtration through a membrane with a nominal pore size not greater than 0.45 μm, using R2A agar and incubating at 30-35 °C for not less than 5 days. The size of the sample is to be chosen in relation to the expected result.

微生物监测

在生产和其后的存储过程中，采取适当的方式以确保水的微生物数受到足够的控制和监测。设置适当的警戒限和行动限以检测不利趋势。在正常条件下，用公称孔径不大于0.45μm微孔滤膜过滤后，采用R2A琼脂于30-35°C下培养至少5天，微生物限度的行动限是100CFU/mL。检测所用的样品量根据期望的结果进行选择。

Yeast extract /酵母膏0.5g

Proteose peptone/蛋白胨0.5g

Casein hydrolysate/水解酪蛋白0.5g

Glucose/葡萄糖0.5g

Starch/淀粉0.5 g

Dipotassium hydrogen phosphate/磷酸氢二钾0.3 g

Magnesium sulfate, anhydrous/无水硫酸镁0.024 g

Sodium pyruvate/丙酮酸钠0.3 g

Agar/琼脂15.0 g

Purified water/纯化水可达1000 mL

Adjust the pH so that after sterilisation it is 7.2 ± 0.2. Sterilise by heating in an autoclave at 121 °C for 15 min.

适当调整pH，使灭菌后的pH为7.2 ±0.2。通过121 °C高压灭菌锅中加热15分钟进行灭菌。

Growth promotion of R2A agar

—Preparation of test strains. Use standardised stable suspensions of test strains or prepare them as stated in Table 0008.-1. Seed lot culture maintenance techniques (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot. Grow each of the bacterial strains separately as described in Table 0008.-1. Use buffered sodium chloride-peptone solution pH 7.0 or phosphate buffer solution pH 7.2 to make test suspensions. Use the suspensions within 2 h, or within 24 h if stored at 2-8 °C. As an alternative to preparing and then diluting a fresh suspension of vegetative cells of Bacillus subtilis, a stable spore