USP-NF Stimuli Article on Stability of Compounded Preparations

In the Pharmacopeial Forum, PF 50(6), a Stimuli article entitled "Stability Reference Document for Pharmaceutical Compounding" was published.

The document does not replace official USP text but provides additional insights into stability practices. According to the authors, the article is "to help compounders further understand and perform stability studies used to establish or extend the Beyond-Use Dates (BUDs)." Specifically, it is intended to assist compounders in understanding the following 2023 revisions to USP general chapters:

• Pharmaceutical Compounding—Nonsterile Preparations <795>
• Pharmaceutical Compounding—Sterile Preparations <797>
• Hazardous Drugs—Handling in Healthcare Settings <800>
• Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging <825>

The article covers key aspects such as physical, chemical, and microbiological stability, including methods to determine stability, potential causes of degradation (e.g., hydrolysis, oxidation, photo-oxidation), and factors that affect drug stability, like temperature, pH, and container type. The document also covers method development and method validation. Compounders are advised to use validated stability-indicating methods to detect degradants and impurities and ensure the stability of active pharmaceutical ingredients.

The authors conclude: "Stability is a critical aspect of compounded dosage forms, ensuring that the preparation maintains intended properties over time. [...] For compounders, a thorough understanding of stability is essential to understand the risk assessments applied in <795> and <797>, as well as to perform and analyze studies proposing extended BUDs. [...] Compounders can use this knowledge to determine assignment of appropriate BUDs based on <795> and <797>, as well as assessing the adequacy of stability studies published in the literature."

The full article is available on PF Online via the USP Website Access Point. The deadline for submitting comments is 31 January 2025.