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HPLC analyses regulatory aspects

There are numerous guidelines which outline the regulatory aspects of HPLC analysis available on the internet. Table 4 represents some of the regulatory authorities and their associated websites. [Pg.290]

This chapter reviews the use of HPLC in pharmaceutical analysis from drug discovery to quality control. The focus is on HPLC analysis of drug substances (DS) and products (DP) such as assay for potency, purity evaluation, and dissolution testing. A case study of the various HPLC methods used during early clinical development illustrates the versatility of this technique. Detailed descriptions of HPLC applications in pharmaceutical development and LC/MS analysis in drug discovery and bioanalytical studies can be found elsewhere.1-6 The regulatory aspects in pharmaceutical testing are covered in Chapter 9. [Pg.136]

REGULATORY ASPECTS OF HPLC ANALYSIS HPLC SYSTEM AND METHOD VALIDATION... [Pg.221]

See other pages where HPLC analyses regulatory aspects is mentioned: [Pg.535]    [Pg.222]    [Pg.224]    [Pg.226]    [Pg.228]    [Pg.230]    [Pg.232]    [Pg.234]    [Pg.236]    [Pg.238]    [Pg.240]   


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HPLC analysis

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