The role of assay methods in characterizing the quality of bulk pharmaceuticals
This study presents the role of assay methods in characterizing the quality of bulk substances in pharmaceutical analysis. High-performance liquid chromatography (HPLC) is the most remarkable development and the technique has become very significant in the quality control of bulk drugs and pharmaceu...
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| Format: | Book |
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Wolters Kluwer Medknow Publications,
2010-01-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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| Summary: | This study presents the role of assay methods in characterizing the quality of bulk substances in pharmaceutical analysis. High-performance liquid chromatography (HPLC) is the most remarkable development and the technique has become very significant in the quality control of bulk drugs and pharmaceutical formulations, even at the pharmacopoeial level. Development of HPLC and other chtromatographic techniques, coupled with mass spectrometry, is also useful in the determination of drugs and their metabolites in biological samples. The role of electrophoretic, spectroscopic, and other methods in pharmaceutical analysis are discussed here. There are separate sections devoted to microscopy techniques that are useful in the pharmaceutical field, as also the regulatory aspects of drug analysis, with emphasis on questions related to validation. |
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| Item Description: | 0975-7406 0976-4879 10.4103/0975-7406.67007 |