Skip to main content
SpringerLink
Log in

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

  • Research Paper
  • Published:
Pharmaceutical Research Aims and scope Submit manuscript

Abstract

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 <711> 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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. G . Deng, A. J. Ashley, W. E. Brown, et al. The USP performance verification test, part I: USP Lot P Prednisone Tablets—quality attributes and experimental variables contributing to dissolution variance. DOI 10.1007/s11095-007-9498-7 (2008)

  2. USP, USP 30–NF 25, Dissolution <711>, Apparatus Suitability Test, US Pharmacopeial Convention, Inc., Rockville, MD, 2006, p. 282.

  3. ISO, Guide 43-1. Proficiency Testing by Interlaboratory Comparisons—Development and Operation of Proficiency Testing Schemes, 2nd ed., ISO, Geneva, Switzerland, 1997.

  4. USP, USP 30–NF 25, Validation of Compendial Procedures <1225>. US Pharmacopeial Convention, Inc., Rockville, MD, 2006, pp. 680–683.

  5. ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology.www.ich.org/LOB/media/MEDIA417.pdf. Accessed June 28, 2007.

  6. R. A. Johnson and D. W. Wichem, Applied Multivariate Statistical Analysis, fifth edition, Upper Saddle River, NJ: Prentice Hall, 2002.

  7. W. W. Hauck, V. P. Shah, S. W. Shaw, and C. T. Ueda Reliability and reproducibility of vertical diffusion cells for determining release rates from semisolid dosage forms. Pharm. Res. 24:2018–2024 (2007).

  8. ISO. Guide 5725. Accuracy (Trueness and Precision) of Measurement Methods and Results—Part 6: Use in Practice of Accuracy Values, ISO, Geneva, Switzerland, 1994.

  9. W.W. Hauck, R.G. Manning, T.L. Cecil, W. Brown, and R.L. Williams. Proposed changed to acceptance criteria for dissolution performance verification testing . Pharm. Forum. 33:574–579 (2007).

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland, 20852, USA

    Maria Glasgow, Shawn Dressman, William Brown, Stefan Schuber, Samir Z. Wahab, Roger L. Williams & Walter W. Hauck

  2. USP 2005–2010 Biopharmaceutics Expert Committee, University of Kentucky Medical Center College of Pharmacy, Lexington, Kentucky, USA

    Thomas Foster

  3. Department of Health and Human Services, Washington, DC, 20201, USA

    Ronald G. Manning

Authors
  1. Maria Glasgow
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Shawn Dressman
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. William Brown
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Thomas Foster
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Stefan Schuber
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ronald G. Manning
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Samir Z. Wahab
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Roger L. Williams
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Walter W. Hauck
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Roger L. Williams.

Additional information

This article is Part II of a two-part article appearing in this issue.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Glasgow, M., Dressman, S., Brown, W. et al. The USP Performance Verification Test, Part II: Collaborative Study of USP’s Lot P Prednisone Tablets. Pharm Res 25, 1110–1115 (2008). https://doi.org/10.1007/s11095-007-9482-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11095-007-9482-2

Key words

Search

Navigation