某产品拟在日本注册,该产品收载入日本药典各论,日本药典各论Description项下描述该产品溶液(1→20)无旋光性,请问是否需要把旋光度定入拟注册质量标准。。
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2025-11-26 13:24 张焱     
1个回答

JP general notice中具体规定如下:该类内容作为参考信息,不作为标准符合性判定。

5. The JP Drugs are to be tested according to the
provisions given in the pertinent monographs, General
Notices, General Rules for Crude Drugs, General
Rules for Preparations, and General Tests for their
conformity to the Japanese Pharmacopoeia. However,
the headings of ``Description'' and in addition ``Containers
and storage'' and ``Shelf life'' in the monographs
on preparations are given for information, and
should not be taken as indicating standards for conformity.

Nevertheless, Containers under ``Containers
and storage'' in the monograph on preparations containing
crude drugs as main active ingredients are the
standards for conformity.

2025-11-28 17:16 沐清风