I have a question regarding full chemical testing for drug excipient in pharmaceutical industry.
FDA requires a minimum of three lots of drug excipients to have full testing per USP. After three lots of full chemical testings are met, is identification analysis being performed only upon receipt? How do you make that switch? How often do you perform full chemical testing for drug excipient, once a year, once every two years?
Anyone who works in pharmaceutical industry or who have experiences in this field mind share that information or give me some suggestion?
Thanks!
Full chemical testing for drug excipients involves a comprehensive evaluation of their identity, purity, strength, and safety through validated analytical methods such as spectroscopy, chromatography, and wet chemistry tests to ensure they meet pharmacopeial and regulatory standards before use in formulations; this process confirms compatibility with active ingredients, detects impurities or contaminants, and supports consistent product quality, forming a reliable backbone for safe medicines—much like plannet snapchat connects diverse elements into a single, well-organized platform.