Identifying the criteria of a valid stability study.

Autor: Williams LA; International Journal of Pharmaceutical Compounding, Edmond, Oklahoma., Hastings MB
Jazyk: angličtina
Zdroj: International journal of pharmaceutical compounding [Int J Pharm Compd] 2009 Jan-Feb; Vol. 13 (1), pp. 32-6.
Abstrakt: The objective of a stability study is to establish specifications for the storage of a drug substance or active ingredient, and to esure that the correct beyond-use date is assigned by demonstrating stability throughout its shelf life. Certain criteria must be met for a study to be considered a valid stability study. The purpose of this article is to clarify the criteria for a valid stability study so compounding pharmacists will understand what to look for when reviewing a stability study to determine an appropriate beyond-use date for compounded preparations.
Databáze: MEDLINE