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 the American pharmaceutical industry to provide instructions for verifying compendial procedures.Pappa...
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...
USP General Chapter 41 "Balances” is mandatory and states the requirements for balances used for materials that must be accurately weighed. Weighing should be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy. ...
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 ...
USP34 General chapter index 热度: USP General Chapter 《1010》 Analytical Data – Interpretation 热度: High Performance Liquid Chromatography USP General Chapter 高效液相色谱USP通则 热度: 相关推荐 GeneralChapteronInorganicImpurities:HeavyMetals USPAdHocAdvisoryPanelonInorganicImpuritiesandHeavyMetalsand ...
17.https://www.edqm.eu/en/news/ph-eur-launches-public-consultation-new-general-chapter-analysis-n-nitrosamines 18.http://www.cde.org.cn/news.do?method=largeInfo&id=1b252859e588d725 19.http://www.cde.org.cn/news.do?method=larg...
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The United States Pharmacopeia (USP) General Chapter <800>, is a standard written to provide guidance when working with Hazardous Drugs (HDs), in an effort to mitigate worker exposure to HDs. This chapter has been published in the First Supplement to USP 39-NF 34. ...