作业帮英语翻译RESULTS AND INTERPRETATIONWhen verifying the suitability
来源：学生作业帮 编辑：作业帮 分类：英语作业 时间：2024/05/18 09:35:03
英语翻译
RESULTS AND INTERPRETATION
When verifying the suitability of the membrane filtration method or the plate-count method,a mean count of any of the test organisms not differing by a factor greater than 2 from the walue of the control defined in inoculation and dilution in the absence of product must be obtained.when verifying the suitability of the MPN method ,the calculated value from from the inoculum must be within 95％ confidence limits of the results obained with the control .
If the above criteria cannot be met for for one of more of the organisms tested with any of the described methods ,the method and test conditiongs that come closest to the criteria are used to test the product.
TESTING OF PRODUCTS
AMOUNT USED FOR THE TEST
Unless otherwise directed,use 10 g or 10 ml of the product to be examined taken with the precautions referred to above .for fluids or solids in aerosol form ,sample 10 containers.for transdermal patches ,sample 10 patches.
The amount to be tested may be rebuced for active substances that will be formulated in the following conditions:the amount per dosage unit (e.g ,tablet,capsule,injection)is less than or equal to 1 mg .or the amount per g or ml (for preparations not presented in dose units)is less than I mg .in these cases ,the amount of sample to be tested is not less than the amount present in 10 dosage units or 10 g or 10 ml of the product.
For materials used as active substances where the sample quantity is limited or biatch size is extremely small(i.e,less than 1000 ml or 1000 g ),the amount tested shall be 1％ of the batch unless a lesser amount is prescribed or justified and authorized.
Foe products where the total number of entities in a batch is less than 200(e.g samples used in clinical trials),the sample size may be reduced to two units ,or one uint if the size is less than 100.
Select the samle(s) at random from the bulk material or from the available containers of the preparation.To obtain the required quantity,mix the contents of a sufficient number of containers to provide the sample.
RESULTS AND INTERPRETATION
When verifying the suitability of the membrane filtration method or the plate-count method,a mean count of any of the test organisms not differing by a factor greater than 2 from the walue of the control defined in inoculation and dilution in the absence of product must be obtained.when verifying the suitability of the MPN method ,the calculated value from from the inoculum must be within 95％ confidence limits of the results obained with the control .
If the above criteria cannot be met for for one of more of the organisms tested with any of the described methods ,the method and test conditiongs that come closest to the criteria are used to test the product.
TESTING OF PRODUCTS
AMOUNT USED FOR THE TEST
Unless otherwise directed,use 10 g or 10 ml of the product to be examined taken with the precautions referred to above .for fluids or solids in aerosol form ,sample 10 containers.for transdermal patches ,sample 10 patches.
The amount to be tested may be rebuced for active substances that will be formulated in the following conditions:the amount per dosage unit (e.g ,tablet,capsule,injection)is less than or equal to 1 mg .or the amount per g or ml (for preparations not presented in dose units)is less than I mg .in these cases ,the amount of sample to be tested is not less than the amount present in 10 dosage units or 10 g or 10 ml of the product.
For materials used as active substances where the sample quantity is limited or biatch size is extremely small(i.e,less than 1000 ml or 1000 g ),the amount tested shall be 1％ of the batch unless a lesser amount is prescribed or justified and authorized.
Foe products where the total number of entities in a batch is less than 200(e.g samples used in clinical trials),the sample size may be reduced to two units ,or one uint if the size is less than 100.
Select the samle(s) at random from the bulk material or from the available containers of the preparation.To obtain the required quantity,mix the contents of a sufficient number of containers to provide the sample.
当验证方法的适用性或plate-count膜过滤方法,意味着计数的任何测试不同生物的一个因素不大于2的控制walue定义在接种和稀释在缺乏的产品必须温升的适用性验证MPN法,由前者计算值必须在95%的置信极限的结果与控制根据藏东.
如果不能满足上述标准为之一的有机体的描述测试方法相比较,这种方法和测试conditiongs最接近的标准,是用来测试产品.
产品测试等
用量进行试验
除非另有指示,使用10克或者十毫升的产品进行检查被预防.因为液或上述提到的固体形式,10 containers.for气溶胶样品,样品透皮贴剂10补丁.
测试的数额可能rebuced活性物质,为制定在下列条件:金额剂量单位(例如,片剂、胶囊剂、注射)是小于或等于1毫克金额或者克制备毫升没有介绍在剂量单位)小于我毫克.这种情况下,数量的样品测试金额不得低于目前在10年或10克剂量单位或10毫升的产品.
材料作为活性物质在样本数量有限或biatch是极其微小的尺寸(如下,不到1000毫升或1000克),数量1%的测试,除非有一个小批数量是正当和授权约定或者.
敌人的产品,而总人数的一批单位在低于200(例如样品用于临床试验的样本),可以减少以两个单位,或者一个uint如果大小是少于100.
选择samle(s)随意地从松散材料的容器或可用做准备工作.
如果不能满足上述标准为之一的有机体的描述测试方法相比较,这种方法和测试conditiongs最接近的标准,是用来测试产品.
产品测试等
用量进行试验
除非另有指示,使用10克或者十毫升的产品进行检查被预防.因为液或上述提到的固体形式,10 containers.for气溶胶样品,样品透皮贴剂10补丁.
测试的数额可能rebuced活性物质,为制定在下列条件:金额剂量单位(例如,片剂、胶囊剂、注射)是小于或等于1毫克金额或者克制备毫升没有介绍在剂量单位)小于我毫克.这种情况下,数量的样品测试金额不得低于目前在10年或10克剂量单位或10毫升的产品.
材料作为活性物质在样本数量有限或biatch是极其微小的尺寸(如下,不到1000毫升或1000克),数量1%的测试,除非有一个小批数量是正当和授权约定或者.
敌人的产品,而总人数的一批单位在低于200(例如样品用于临床试验的样本),可以减少以两个单位,或者一个uint如果大小是少于100.
选择samle(s)随意地从松散材料的容器或可用做准备工作.