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标题: USP修订约30个眼膏各论 [打印本页]

作者: aiyao    时间: 2016-9-8 03:21 PM
标题: USP修订约30个眼膏各论

USP revised about thirty Ophthalmic Ointment Monographs

USP修订约30个眼膏各论

On July 29, 2016, the United States Pharmacopeia (USP) posted a new Revision Bulletin regarding approximately thirty Ophthalmic Ointment Monographs.The revised monographs became official on August 1, 2016.

2016年7月29日,USP发布了关于近30个眼膏各论的新修订版本。修订后的各论针于2016年8月1日正式公布。

The USP Chemical Medicines Expert Committees 1 to 6 have revised the monographs following the revision of general chapter <771> which became official on May 1, 2016 (USP 39).

USP化学药物专家委员会1-6已经根据通则修订<771>开始对各论进行修订,它已于2016年5月1日生效(USP39)。

The purpose of the revision is to replace the requirement to comply with the entire content of the USP general chapter Ophthalmic Products—Quality Tests <771> (whose former title was Ophthalmic Ointments) with a requirement to comply only with the subsection for Particulate and Foreign Matter in Ophthalmic Products—Quality Tests <771>, and with the section for Container Content for those monographs where the requirement for Minimum Fill was deleted.

修订的目的是替代这些要求,以符合USP眼膏通则的整个内容---质量检测<771>(它之前的标题是眼膏剂),以符合眼用药品---质量检测<771>中的颗粒和异物子部分,符合这些各论的容器内容部分,这些部分里已经将最小充填要求删除了。

The Revision Bulletins for the respective monographs supersede the currently official version of these monographs. The Revision Bulletin will be incorporated in the First Supplement to USP 40–NF 35.

相关各论的修订公告将取代这些各论的当前正式版本。修订公告将会进入USP40-NF35第一次增补中。

For more information please visit the USP Revision Bulletins website.

更多信息请参见USP修订公告网站。








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