WATER, PURIFIED
纯化水H2O Mr18.12DEFINITION
Water for the preparation of medicines other than tho that are required to be both sterile and apyrogenic,unless otherwi 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
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。效益评估
Microbiological monitoring During production and subquent storage,appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored. Appropriate alert and action levels are t so as to detect adver 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
0.45μm,using R2A agar and incubating at 30-35°C for not less than 5days.The size of the sample is to be chon 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xx不大于
wavingflag0.45μm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
coffee shop音译0.5g
Proteo peptone/蛋白胨
0.5g
Cain hydrolysate/水解酪蛋白
0.5g
Gluco/葡萄糖
0.5g如何美白脸
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/xx
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. Sterili by heatingin 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. U standardid stable suspensions of test strains or prepare them as stated in Table
0008.-eskape
员工关怀1.Seed lot culture maintenance techniques (ed-lotsystems)are ud so that the viable
micro-organisms ud for inoculation are not more than 5passages removed from the original master ed-lot.Grow each of the bacterial strains parately as described in Table
0008.-
1.U buffered sodium chloride-peptone solution pH
7.0 or phosphate buffer solution pH
7.2 to make test suspensions. U the suspensions within 2 h, or within 24 h if stored at 2-8 °
brothers and sistersC. As an alternative to preparing and then diluting a fresh suspension of vegetative cells of Bacillus subtilis,a stable spore
suspension is prepared and then an appropriate volume of the spore suspension is ud for test inoculation. The stable spore suspension may be maintained at 2-8 °C for a validated period of time.
R2Axx促生长试验：
测试菌株的制备：
使用标定过的稳定的测试菌悬浮液或按表
电子字典
0008.-1中所述的方法制备。采用适当的菌株批保藏技术以保证菌株从原始菌株中传代次数不超过5代。根据表德语好学吗
0008.-1描述，每次菌株分开培养。
使用pH为
yousheng7.0的氯化钠-蛋白胨缓冲溶液或pH为
7.2的磷酸盐缓冲液制备测试悬浮液。悬浮液应在2小时内使用，如保存在2-8°C则可在24小时内使用。作为制备并稀释枯草芽孢杆菌营养细胞新鲜悬浮液的替代方法，也可以制备稳定的孢子悬浮液，然后使用体积适合的孢子悬浮液进行接种测试。孢子悬浮液需在2-8°
C、且已验证的期限内保存。
—Growth promotion.Test each batch ofready-prepared medium and each batch of medium, prepared either from dehydrated medium or from theingredients described. Inoculate plates of R2A agar parately with a small number(not more than 100 CFU)of the micro-organisms indicatedin Table
