World expirience of the expiration date determination of compounding preparations
Today, in practice of compounding pharmacies there are a number of contradictions and questions about the stability study, expiration dates setting and storage conditions for compounding preparations and active pharmaceutical ingredients which used in preparing of compounding preparations. This article focuses on review of normative base of Ukraine regarding compounding preparations expiry date determination, and international experience analysis concerning approaches of stability and expiration date determination.
Materials of research were monographs of State Pharmacopoeia of Ukraine, and Pharmacopeia of the US, Ministry of Health of Ukraine Decrees, Guides of ICH, PIC/S to the quality system for hospital pharmacies, Good Pharmacopoeial Practices in which the basic requirements to the expiration dates determination and storage conditions for sterile and non-sterile compounding preparations are given.
A comparison of approaches to stability determination and maximum expiration dates of sterile and non-sterile CP was carried out using the methods of analysis, synthesis and data summarizing.
Thus, the guiding principles of expiration dates determination of compounding preparations were identified, such as: experimental studies, the use of the scientific literature data, accounting of contamination risks, type of the dispersion medium of compounding preparations, and accounting of ingredients expiration dates.
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