| Development of a Performance Verification Test for USP Apparatus 4. | |
| | |
MedLine Citation:
|
PMID: 21826572 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
PURPOSE: To evaluate salicylic acid tablets as a candidate reference material in a Performance Verification Test (PVT) when a USP performance test for dissolution (General Chapter <711>) relies on USP Apparatus 4 (flow-through cell). METHODS: We developed a dissolution procedure relying on Apparatus 4 and salicylic acid tablets. Thereafter, a designed experiment was conducted to identify operational variables that significantly affect salicylic acid dissolution in this apparatus. RESULTS: Four variables (size of glass beads, cell temperature, flow rate, level of deaeration) and one combination effect (deaeration/bead size) were significant for mean percent dissolved. Two variables (tablet orientation, level of deaeration) were significant for standard deviation results, but these effects were less pronounced than those for mean percent dissolved results. Three variables (analyst, tester manufacturer, amount of glass beads) had no statistically significant effects on either the mean or standard deviation of the responses. CONCLUSIONS: The proposed PVT is capable of probing effects of changes in several critical operational parameters of Apparatus 4. Salicylic acid tablets were shown to be a suitable reference material for the PVT. The PVT using salicylic acid tablets satisfies important aspects of a PVT. |
| | |
Authors:
|
Joseph W Eaton; Daren Tran; Walter W Hauck; Erika S Stippler |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2011-8-9 |
Journal Detail:
|
Title: Pharmaceutical research Volume: - ISSN: 1573-904X ISO Abbreviation: - Publication Date: 2011 Aug |
Date Detail:
|
Created Date: 2011-8-9 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8406521 Medline TA: Pharm Res Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
|
US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790, USA, jwe@usp.org. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Aqueous-methanolic extract of sweet flag (Acorus calamus) possesses cardiac depressant and endotheli...
Next Document: Antiviral RNAi: Translating Science Towards Therapeutic Success.