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United States Pharmacopeia monographs establish standards for identity, strength, quality, and purity of medicines. Monographs list tests and acceptance criteria (usually expressed in percentage ranges or limits). Drug substances and products should meet the acceptance criteria to be considered acceptable for its intended use.

Minor Chapters, Major Impacts – What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> mean for your compounding practiceBrian Kelley, BS, ARL Bio Pharma Director of Business DevelopmentInternational Journal of Pharmaceutical Compounding, Vol. 25, No. 2, March / April 2021, p. 115-124 Abstract The United States Pharmacopeial Convention, Inc. recommends within the standards of

James Zellner, ARL Bio Pharma Technical Sales and Microbiologist USP <60>, Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex, describes a test procedure that evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations.  This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that

Evelyn Orona, Associate Microbiology Supervisor Just as crucial as the sterile production of drug products is ensuring those same products are free of dangerous pyrogens – contaminants that induce febrile reactions in patients if introduced at high levels. Relative to patient safety, the most concerning and common pyrogen is bacterial endotoxins. Pyrogens can be removed or

Drug components differ in purity, specifications and quality. According to FDA draft guidance, it’s important for compounding pharmacies and outsourcing facilities to verify drug components purchased from suppliers. Pharmacists verify drug components by: The FDA draft guidance for 503B outsourcing facilities states that “in lieu of testing each shipment of each ingredient, a COA can

Ophthalmic medications must meet particulate matter test requirements. Particulate matter may come from foreign or product-related substances. Clinical exposure to unwanted particulate matter can cause a biological response in patients including blocking capillaries and arteries, introducing microorganisms and causing an infection, or causing an allergic reaction.  Ophthalmic products fall into three route of administration categories: USP