These Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. 这些药典规定程序自身的设计不能确保一批产品无菌或已经灭菌。
If they occur, the Pharmacopeial and NDA impurity limits and rationale should be reviewed; 如果发生变化,应检查药典和NDA杂质限定和原理;
Pharmacopeial articles should include required storage conditions on their labeling. 药典收载的药物制剂的标签应标明贮存条件。
Pharmacopeial articles are to be tested by the Membrane Filtration method under Test for Sterility of the Product to be Examined where the nature of the product permits. 只要其性质许可,这些药品将使用供试产品无菌检查法项下的膜过滤法来检测。
Result: The result showed that there was no significant difference between pharmacopeial and improved method. 结果:改进法与药典法比较,测定结果无明显差异。
On the abnormal employment And abnormal toxicity experiment was made on the mouse according to the pharmacopeial standard. 按药典规定用小白鼠做异常毒性试验。
Methods: The sample was dissolved in chloroform, the starch no in chloroform was filtered, filtrate was evaporated to dryness on the water bath and then identified according to the pharmacopeial method. 方法:对鉴别的样品进行前处理,取样品适量,加氯仿溶解,将不溶于氯仿的淀粉滤过除去,滤液置水浴上蒸干,然后按药典方法进行鉴别。