METHODS AND ASSEMBLIES FOR CONTROL OF FORMATION OF NITROSAMINE IMPURITIES IN SOLID ACTIVE PHARMACEUTICAL INGREDIENTS
개요
발명자
Natwar PANCHAL; Madhu SADASHIVAIAH; Venu Babu GORIPARTHI; Sanjani VANGULE; Sandip PAWAR
IPC 분류
CPC 분류
The present invention relates to the field of impurities control, in particular genotoxic impurities, in active pharmaceutical ingredients (APIs). In particular, the present invention relates to a packaging method and assembly for the control of the formation of a nitrosamine, for example 1-methyl-4-nitrosopiperazine (MeNP), in a solid active pharmaceutical ingredient (API), for example rifampicin, during storage.
원문 (중국어)
The present invention relates to the field of impurities control, in particular genotoxic impurities, in active pharmaceutical ingredients (APIs). In particular, the present invention relates to a packaging method and assembly for the control of the formation of a nitrosamine, for example 1-methyl-4-nitrosopiperazine (MeNP), in a solid active pharmaceutical ingredient (API), for example rifampicin, during storage.