impurity substance
- impurity substance的基本解释
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杂质
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Lack of information on the description of its route of synthesis, absence or insufficience of its impurity profile (related substances, reagents, solvents, catalysts), and the carry-over of its impurities to the final substance (58.5% of dossiers).
缺少如下资料:起始原料合成路线的叙述,起始原料的杂质概况(有关物质,试剂,溶剂,催化剂)没有或不充分,起始物料中杂质携带至原料药中的情况(申请文件的58.5%)。
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A steel bar is washed and dried, and then put into a glass pipe which is sealed to obtain stirring magneton; a mixed solvent of Gamma-methacrylate oxide propyl trimethoxy silane and methanol is prepared and added with an organic base to obtain a pre-bonding solvent; the stirring magneton is immerged into the pre-bounding solvent, and the outer surface of the glass pipe of the stirring magneton is bonded with a layer of silane substance with alkenyl; a reactive monomer mixture and a pore-forming agent mixed solvent are evenly mixed and then added into a container, the stirring magneton after the pre-bounding is put into the container which is sealed and then put into a water bath; after reaction, the container is removed, the stirring magneton coated with a polymer is taken out and put into a extractor and extracted by using a solvent; or the stir bar is immersed into the solvent till no impurity can be checked in the solvent, thereby obtaining the product.
将铁条清洗干燥,放入玻璃管内,密封得搅拌磁子;配制γ-甲基丙烯酸氧丙基三甲氧基硅烷与甲醇的混合溶液,加入有机碱得预键合溶液,将搅拌磁子浸入预键合溶液,在搅拌磁子的玻璃管外壁键合一层带烯基的硅烷化物质;将反应单体混合剂和致孔剂混合溶液混匀后倒入容器中,将预键合后的搅拌磁子放入容器,密封后置于水浴中,反应后除去容器,取出涂有聚合物的搅拌磁子,置于提取器中,以溶剂提取,或将搅拌棒置于溶剂中浸泡至溶剂中无杂质检出,得产物。
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If they occur, the Pharmacopeial and NDA impurity limits and rationale should be reviewed; the limits should be revised when indicated to ensure similar or improved quality of the drug substance.
如果发生变化,应检查药典和NDA杂质限定和原理;为确保原料药的相似或改善质量时,应修改限度。
- 更多网络解释与impurity substance相关的网络解释 [注:此内容来源于网络,仅供参考]
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impure substance:不纯物质
impulse 脉冲 | impure substance 不纯物质 | impurity 不纯物质