This chapter can be used as an alternative to USP general chapter Particulate Matter in Injections 〈788〉. It specifically addresses therapeutic protein injections and related preparations, allowing use of smaller test product volumes and smaller test aliquots to determine particulate matter content, with sample-handling instructions that ...

Learn how USP’s Particle Count Set Reference Standards, along with USP General Chapters and USP Education webinars, can be used to calibrate particle count analyzers and other particle analysis instrumentation.

Learn about USP’s portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods.

Este capítulo se puede usar como alternativa al capítulo general Partículas en Inyectables 〈788〉 de la USP. Este capítulo trata específicamente de inyectables de proteínas terapéuticas y preparaciones relacionadas, lo cual permite el uso de volúmenes de los productos y alícuotas de prueba más pequeñas para determinar el contenido ...

2023年11月1日 · USP General Chapter 797> describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations.

2023年5月1日 · USP provides answers to Frequently Asked Questions (FAQs) as a service to stakeholders and others who are seeking information regarding USP’s organization, standards, standards-setting process, and other activities.

2022年9月20日 · The series will focus on USP General Chapters <787>, <788>, <1787>, and <1788>, which address particles observed in injections in the subvisible range. Discussions will cover the evolution of USP chapters, methods and requirements, concepts of method qualification, and other technical considerations.

INTRODUCTION. Parenteral products are designed and manufactured to minimize particulate matter, which is differentiated into two broad categories: visible and subvisible.

USP <787>: Emphasizes careful dilution and pooling to avoid introducing particles, particularly for protein formulations with small volumes. ...

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