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www.thinkSRS.com Determination of Melting Points According to Pharmacopeia Application Note #4 Introduction The development and manufacturing of pure chemicals requires that close attention be paid to purity, quality, stability and safety to ensure that the final product performs as intended. One of the analytical techniques applied to the characterization of pure chemicals and pharmaceutical drugs (from raw material, to scale-up, to finished form) is the melting point (MP) determination. Carefully choosing the MP determination procedure is important for generating certifiable results for chemical quality control (QC) and quality assurance (QA). In addition to following well-defined guidelines for Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), pharmaceutical QC/QA labs must also follow multiple strict chemical analysis protocols set forth by local, national and even international Pharmacopeias. Analytical QC/QA laboratories must calibrate their MP instrumentation on a regular basis against certified reference standards (CRSs), to determine whether their instruments are in accordance with the specific requirements defined by their local, national and international standards laboratories. Stanford Research Systems Phone: (408) 744-9040 www.thinkSRS.com Determination of Melting Points According to Pharmacopeia This application note describes some of the most widely accepted Pharmacopeia protocols for MP determinations, and also includes a comprehensive listing of CRSs commonly used for the calibration/validation of MP instrumentation. Important! Pharmacopeia procedures and CRSs are routinely updated, supplemented, reformulated and revised. Use the information in this application note for reference only, and always consult the latest Pharmacopeia publications and supplements for up-to-date information on MP determination protocols and certification procedures. Stanford Research Systems Phone: (408) 744-9040 www.thinkSRS.com Determination of Melting Points According to Pharmacopeia U.S. Pharmacopeia The United States Pharmacopeia (USP, http://www.usp.org/) is a non- governmental, non-profit organization comprising of volunteer scientists. It publishes the U.S. Pharmacopeia and National Formulary (USP-NF) which contains the official, legally recognized standards for pharmaceutical manufacturing. MP Protocol The MP Determination procedure is described in section <741>, p. 2033-2034 of the USP25-NF20 US Pharmacopeia. Five procedures for the determination of melting range or temperature are provided, varying in accordance with the nature of the substance. USP-compatible capillaries are specified for MP determinations: 10 cm length, 0.8 - 1.2 mm internal diameter and 0.2 - 0.3 mm wall thickness. Capi