查询词典 impurity substance

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%）。

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。

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。

It is also known as one of the most poisonous naturally occurring substances.

它也被称为一个最自然发生的有毒物质。

The greatest stress is found at the location on the cross section where V is the largest.

最大应力出现在横截面上V为最大的地方。