Requirements to HPLC systems suitable for quality control of parent substances and dosage forms

The criteria (characteristics and their permissible values) for estimating the suitability of a chromatographic system intended for HPLC quality control of parent drugs and dosage forms are considered. Practical recommendations concering the HPLC system suitability criteria are formulated.

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Veröffentlicht in:Pharmaceutical chemistry journal 2008-11, Vol.42 (11), p.637-643
Hauptverfasser: Epshtein, N. A, Emshanova, S. V
Format: Artikel
Sprache:eng
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Zusammenfassung:The criteria (characteristics and their permissible values) for estimating the suitability of a chromatographic system intended for HPLC quality control of parent drugs and dosage forms are considered. Practical recommendations concering the HPLC system suitability criteria are formulated.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-009-0194-2