Allen Loyd V
International Journal of Pharmaceutical Compounding.
Int J Pharm Compd. 2019 Mar-Apr;23(2):135-143.
The USP has financially supported a number of stability studies for formulations that are being prepared to become official in the United States Pharmacopeia-National Formulary. The United States Pharmacopeia compounded formulation monographs contain the Official Name and Definition of the preparation, along with other information including, but not limited to, tests for Identification, Assay, Limits, Impurities, Specific Tests (pH), Packaging, and Storage requirements. There are currently 214 official compounded preparation monographs, of which 178 contain active pharmaceutical ingredients and 36 are monographs for excipients and vehicles. Some of the monographs are carryovers from previous editions, especially those used for flavoring and as vehicles. Most of these official compounded preparation monographs have validated beyond-use dates. This article provides a summary of the monograph names along with information including dosage form, pH, alcohol content, and beyond-use dates at refrigerated and/or room temperature.
美国药典（USP）已为一些正准备在美国药典-国家处方集（USP-NF）中成为法定制剂的稳定性研究提供了资金支持。美国药典复方制剂专论包含制剂的正式名称和定义，以及其他信息，包括但不限于鉴别试验、含量测定、限度、杂质、特定试验（pH值）、包装和储存要求。目前有214个法定复方制剂专论，其中178个含有活性药物成分，36个是辅料和载体专论。一些专论是前几版遗留下来的，尤其是那些用于调味和作为载体的专论。这些法定复方制剂专论中的大多数都有经过验证的有效期。本文提供了专论名称的汇总，以及包括剂型、pH值、酒精含量以及冷藏和/或室温下的有效期等信息。
