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...
present general chapter text that are national USP–NF text, and therefore not part of the harmonized text, are marked with symbols (♦♦) to specify this fact. ♦This chapter describes general procedures, definitions, and calculations of common parameters and generally applicable requirements ...
Ultra-High Speed Analysis of Methods Conforming to New USP General Chapter 621
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 ...
《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...
621CHROMATOGRAPHY INTRODUCTION Thischapterdefinesthetermsandproceduresusedinchromatographyand providesgeneralinformation.Specificrequirementsforchromatographic proceduresfordrugsubstancesanddosageforms,includingadsorbentand developingsolvents,aregivenintheindividualmonographs. Chromatographyisdefinedasaprocedurebywhichsolutesareseparat...
内容提示: 621 CHROMATOGRAPHY INTRODUCTION 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...
《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...