Martin Matt
Professional Compounding Centers of America, Houston, Texas.
Int J Pharm Compd. 2018 Jul-Aug;22(4):303-312.
Compounding pharmacists must separately and collectively evaluate multiple aspects of a compounded sterile preparation when determining their beyond-use date. Considerations include the microbiological risk level, storage temperature, chemical stability, batch size, and whether or not a sterility test will be performed. The United States Pharmacopeia Chapter <797> provides guidance on the maximum beyond-use date allowed solely based on the microbiological risk level associated with the compounding of a sterile preparation. Compounders should select the shortest beyond-use date between the risk-level based beyond-use date and the chemical stability of the compound. When compounding pharmacists intend to provide a compounded sterile preparation with a beyond-use date that exceeds the risk-level based recommendations in United States Pharmacopeia Chapter <797>, they must ensure that their formulations are sterility tested in compliance with United States Pharmacopeia Chapter <71>. United States Pharmacopeia Chapter <71> compliance includes conducting method suitability that is applicable to the strength and batch size that they plan to prepare. Chemical stability must be a separate consideration for each formulation.
在确定无菌制剂的有效期时，配制药剂师必须分别并综合评估无菌制剂的多个方面。考虑因素包括微生物风险水平、储存温度、化学稳定性、批量大小以及是否将进行无菌测试。《美国药典》第<797>章提供了仅基于与无菌制剂配制相关的微生物风险水平所允许的最长有效期的指导原则。配制人员应选择基于风险水平的有效期和制剂化学稳定性两者中较短的有效期。当配制药剂师打算提供有效期超过《美国药典》第<797>章基于风险水平建议的无菌制剂时，他们必须确保其制剂按照《美国药典》第<71>章进行无菌测试。符合《美国药典》第<71>章包括进行适用于他们计划配制的强度和批量大小的方法适用性测试。每种制剂的化学稳定性必须单独考虑。
