Modern approaches to the validation of the pharmacopoeial dissolution test

General approaches to the validation of the pharmacopoeial Dissolution test are considered. The determination of the dissolution validation characteristics (specificity, accuracy, precision, linearity range, and robustness) is described. Specific features for validation of the assay of released drug...

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Bibliographic Details
Published inPharmaceutical chemistry journal Vol. 45; no. 3; p. 183
Main Authors Shokhin, I. E., Ramenskaya, G. V., Davydova, K. S.
Format Journal Article
LanguageEnglish
Published Boston Springer US 01.06.2011
Springer
Subjects
Drug Synthesis Methods and Manufacturing Technology
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
spectrophotometry
validation
HPLC
pharmacopoeial Dissolution test
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Summary:General approaches to the validation of the pharmacopoeial Dissolution test are considered. The determination of the dissolution validation characteristics (specificity, accuracy, precision, linearity range, and robustness) is described. Specific features for validation of the assay of released drug using UV spectrophotometry and HPLC are described.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-011-0588-9