Also known as microbial content or bioburden testing, microbial limit testing evaluates non-sterile pharmaceutical products, nutritional supplements, and dietary supplements for microbial content. Sterile products are tested separately under USP <71> Sterility Test guidelines. Preparatory testing is performed to ensure the accuracy and reliability of results. USP <61> and USP <2021> – Quantitative tests to determine total aerobic microbial count and total combined yeast/mold count. USP <62> and USP <2022> – Qualitative tests for specified organisms that may be present. Any organisms recovered should be assessed for potential impact on user safety and product stability. Clients may refer to USP <1111> or USP <2023> for guidance in selecting the appropriate tests for their product.
