影子
第1楼2010/05/04
没有人关心这个吗?
药典论坛第36卷第1期:A General Notices statement indicating <232> apply to all monographs, even if not specified
凡例中将新增声明:通则<232>适用于所有各论,即使不做特别说明,也就是说如同有机残留溶剂一样,所有产品都必须检测这一项。涉及到的仪器有电感耦合等离子体原子发射光谱仪,电感耦合等离子体质谱仪,一般的实验是没有这种仪器的,因此可能会增加企业的成本,我觉得这一点影响还是很大的。
ljzkevin
第3楼2011/01/15
General Chapter Heavy Metals <231> are inadequate to
provide the basis for control of the elements in <232> at
their proposed limits.
The Chapter
also provides limits of metal catalysts that can be added
in the production of a drug substance or excipient.
This Chapter also
describes three separate options for determination of
compliance to the limits. These options are similar to
those presented in General Chapter Residual Solvents
<467>.
A revision is proposed to the General Notices to indicate
that General Chapters h232i and h233i will apply to all
oral and parenteral articles in USP–NF. This revision is sim-
ilar in content to that describing the residual solvents re-
quirements.
They recommend that
the committee consider an official date that coincides
with the official date of the EMEA Metal Catalyst guide-
line (Sept. 2013).
出口美国及欧盟的得相当注意了,需提前准备!