a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply ...
The article focuses on the US Pharmacopeia's (USP) proposed General Chapter (1226) "Verification of Compendial Procedures". The process of validating a new analytical procedure for compendial usage is addressed in the proposed General Chapter. The article reports on USP's response to request of ...
They contain no mandatory requirements applicable to any official article unless specifically referenced in General Notices, a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply only to articles that are intended for ...
USPGeneralChapter<621>EPGeneralChapter<2.2.46> ColumnLength±70%±70% ColumnI.D.Nolimit,butkeepconstantlinearvelocity±25% ParticleSize-50%-50% FlowRate±50%±50% Temperature±10℃ ±10℃ Maximum60℃ InjectionVolume Acceptableaslongasitsatisfiesthesystem ...
1楼:Originally posted by雪梦蝶at 2017-05-24 19:18:31 求助内容： usp 40，General Chapter <659...
The USP Parenteral Products-Industrial Expert Committee (PPI EC) has worked during the past three revision cycles to revise USP General Chapter Elastomeric Closures for Injection (381). This Stimuli article summarizes these efforts and in the Appendix provides an overview of the current draft revision...
USP39 General Chapter <1225> Validation of Compendial Procedures
applicationoftheHeavyMetalstestdescribedinUSP–NFGeneralChapterHeavyMetals <231>.However,theproceduresandthemethodscontainedin<231>lackthesensitivity, specificity,andrecoverytomonitorproperlythelevelsofthesemetals.Anumberofadditional chaptersforthecontrolofspecificmetalsandotherinorganicimpuritiesarecontainedinUSP– NF....
I ndividual USP or NF monographs as well as certain General Chapters specify the USP Reference Standard(s) required for assay and test procedures. General Chapter <11> USP Reference Standards provides general informa-tion and instructions for proper use and storage. Consult the label text for...
This chapter applies, in whole or in part, when referenced in a drug product monograph (see General Notices, 3.10 Applica- bility of Standards). (RB 1-May-2016) Official from null Copyright (c) 2017 The United States Pharmacopeial Convention. All rights reserved. Accessed from by brunswick20...