PROCEDE DE FABRICATION D'UNE POCHE POUR PERFUSION INTRAVEINEUSE STABLE ET PRETE A L'EMPLOI POUR UNE FORMULATION SENSIBLE A L'OXYDATION

• 收藏
• 分享

专利权人:

INC.;INNOPHARMA

发明人:

HINGORANI, TUSHAR,KUNADHARAJU, SASANK CHAITANYA,MALKAN, TUSHAR,PEJAVER, SATISH

申请号：

CA3013413

公开号：

CA3013413A1

申请日:

2017.01.23

申请国别(地区):

CA

年份:

2017

代理人:

摘要：

A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient (API) is provided, wherein the water is not deoxygenated and a nitrogen blanket is not used during formulation, or the formulation is stored in ambient conditions in the polymer bag and autoclaved. The highest degradation product in the parenteral drug product is less than 0.1% by weight of a labeled amount of the oxidation susceptible API in the parenteral drug product.

来源网站：

中国工程科技知识中心

来源网址：

http://www.ckcest.cn/home/