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

Purpose Periodic performance verification testing (PVT) is used by laboratories to assess and demonstrate proficiency and for other purposes as well. For dissolution, the PVT is specified in the US Pharmacopeia General Chapter Dissolution under the title Apparatus Suitability Test . For Apparatus 1...

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Bibliographic Details
Published in:Pharmaceutical research 2008-05, Vol.25 (5), p.1110-1115
Main Authors: Glasgow, Maria, Dressman, Shawn, Brown, William, Foster, Thomas, Schuber, Stefan, Manning, Ronald G., Wahab, Samir Z., Williams, Roger L., Hauck, Walter W.
Format: Article
Language:English
Subjects:
Algorithms
Biochemistry
Biological and medical sciences
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedical research
Biomedicine
Chemistry, Pharmaceutical
Criteria
General pharmacology
Medical Law
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology
Pharmacology. Drug treatments
Pharmacology/Toxicology
Pharmacopoeias as Topic
Pharmacy
Prednisone - analysis
Prednisone - standards
Product testing
Reference Standards
Reproducibility of Results
Research methodology
Research Paper
Spectrophotometry, Ultraviolet
Tablets
United States
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Summary:Purpose Periodic performance verification testing (PVT) is used by laboratories to assess and demonstrate proficiency and for other purposes as well. For dissolution, the PVT is specified in the US Pharmacopeia General Chapter Dissolution under the title Apparatus Suitability Test . For Apparatus 1 and 2, USP provides two reference standard tablets for this purpose. For each new lot of these reference standards, USP conducts a collaborative study. Methods For new USP Lot P Prednisone Tablets, 28 collaborating laboratories provided data. The study was conducted with three sets of tablets: Lot O open label, Lot O blinded, and Lot P blinded. The blinded Lot O data were used for apparatus suitability testing. Results Acceptance limits were determined after dropping data due to failure of apparatus suitability, identification of data as unusual on control charts, or protocol violations. Conclusions Results yielded acceptance criteria of (47, 82) for Apparatus 1 and (37, 70) for Apparatus 2. Results generally were similar for Lot P compared to results from Lot O except that the average percent dissolved for Lot P is greater than for Lot O with Apparatus 2.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-007-9482-2