Know your exposure to hazardous drugs with the <800>HazRx™ Mobile App. Developing USP General Chapter <795> USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. Background and objective(s): USP intends to develop a new informational general chapter to align with current scientific and regulatory approaches to provide information useful for ensuring the appropriate control of nitrosamine impurities in drug substances and drug products. Preliminary outline: The following represents the sections for the proposed General Chapter. When a general chapter is referenced in a monograph, acceptance criteria may be presented after a colon. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process. The chapter provides suitable performance criteria for analytical procedures used in the Identification and quantification of nitrosamine impurities. time of the test. USP 38General Noticesli GENERAL NOTICES AND REQUIREMENTS The General Notices and Requirementssection (the Generalintended for use as dietary ingredients and dietary Notices) presents the basic assumptions, definitions, and de-supplements. The information is provided for those who use, prepare, and dispense drugs, solely to indicate descriptive and solubility properties of … USP General Chapter <795> provides standards for compounding quality nonsterile preparations. The new reference standards are expected to be available in late spring 2020. [CDATA[> 2020]. Browse and register for courses and webinars offered around the world. Additional Information: USP has developed a comprehensive portfolio of USP Reference Standards for nitrosamine impurities including, N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitrosodiisopropylamine (NDIPA), N-Nitrosodibutylamine (NDBA), N-Nitrosoethylisopropylamine (NEIPA), and N-Nitrosomethylaminobutyric Acid (NMBA). Posting Date: 24–Apr–2020Expert Committee: General Chapters—Chemical AnalysisInput Deadline: 22–May–2020 Proposed New Title: <1469> Nitrosamine Impurities. Anticipated implementation timing: To be determined based on stakeholder feedback. 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