https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/acetaminophen.pdf. USP General Chapter <621>.Accessed 16-Dec-2022. https://www.usp.org/sites/default/files/usp/document/harmonization/gen-chapte...
The USP-NF is a book of pharmacopeial standards that has been designated by the FDA as the official compendia for drugs marketed in the United States. Its chapter on Chromatography is <621>, foundhere, and “defines the terms and procedures used in chromatography and provides general information...
621 CHROMATOGRAPHY 色谱法 INTRODUCTION 介绍 This chapter defines the terms and procedures used in chromatography and provides general information. Specific requirements for chromatographic procedures for drug substances and dosage forms, including adsorbent and developing solvents, are given in the individual ...
physicochemicalpropertiesofthemolecules,suchassize,mass,andvolume.Thischaptercontainsgeneralprocedures,defini- tions,andcalculationsofcommonparametersanddescribesgeneralrequirementsforsystemsuitability.Thetypesofchroma- tographyusefulinqualitativeandquantitativeanalysesemployedinUSPproceduresarecolumn,gas(GC),paper,thin-laye...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中,所有的通则都是强制执行的吗? 回答: 在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定: “2.10. Official Text Official te...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中，所有的通则都是强制...
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 ...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中,所有的通则都是强制执行的吗? 回答: 在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定: “2.10. Official Text Official tex...
This chapter contains general procedures, de?nitions, and calculations of common parameters and describes general requirements forsystem suitability. The types of chromatography useful in qualitative and quantitative analyses employed in USP procedures are column, gas (GC), paper, thin-layer (TLC)[...
The column length and the gradient elution parameters were adjusted following the guidelines in "Adjustment of Chromatographic Conditions" in USP General Chapter <621>. The mobile phase compositions were optimized to meet the system suitability requirements that were specified in the USP melatonin ...