NDLI: The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance

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The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance

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The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance

Content Provider	Springer Nature Link
Author	Deng, Gang Ashley, Alyssa J. Brown, William E. Eaton, Joseph W. Hauck, Walter W. Kikwai, Loice C. Liddell, Mark R. Manning, Ronald G. Muz, Jimmy M. Nithyanandan, Pallavi Glasgow, Maria J. Stippler, Erika Wahab, Samir Z. Williams, Roger L.
Copyright Year	2007
Abstract	Beyond instrumental qualification, proficiency testing is not usually a prerequisite for many analytical procedures, given reliance on a manufacturer’s assay validation coupled with regulatory review and inspection. Given the special features of the dissolution procedure, proficiency testing was put in place initially by pharmaceutical manufacturers and carried on by USP. Proficiency testing is designed to help ensure that execution of a dissolution procedure for solid oral dosage forms adequately supports administrative and legal decisions so that measurements made at different times, by different analysts, or with different methods can be confidently compared. USP has applied metrological principles to aid practitioners in carrying out the dissolution procedure alone and in collaborative studies to facilitate understanding potential sources of variability.The present study aimed to identify key dissolution variables associated with USP Lot P Prednisone Tablets in conjunction with the USP Performance Verification Test (PVT). Using five dissolution test assemblies from different manufacturers, at least four of six analysts determined percents prednisone dissolved on dissolution Apparatus 1 (basket) and Apparatus 2 (paddle) on each assembly. Six replicate experiments were performed on each analyst–assembly combination with a set of six to eight tablets in each experiment.Statistical analysis demonstrated that dissolution test assemblies were the largest factor contributing to dissolution variability. Inherent tablet variability was low, and USP Lot P Prednisone Tablets did not contribute importantly to dissolution variability. Contributions from analyst and analytical procedure also were estimated to be low.
Starting Page	1100
Ending Page	1109
Page Count	10
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	25
Issue Number	5
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2008-01-03
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	dissolution performance verification performance verification test quality assurance United States Pharmacopeia Biomedical Engineering Medical Law Biochemistry Pharmacy Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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The USP Performance Verification Test, Part II: Collaborative Study of USP’s Lot P Prednisone Tablets

Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets—A Technical Note

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Shear-induced variability in the United States pharmacopeia apparatus 2: Modifications to the existing system

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Simulating the hydrodynamic conditions in the united states pharmacopeia paddle dissolution apparatus

Evaluation of the Performance of Prednisone and Salicylic Acid Usp Dissolution Calibrators

Erratum to: “Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard”

Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard

The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance

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The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance