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Analytical Method Validation and Instrument Performance Verification (047146371X) cover image
Analytical Method Validation and Instrument Performance Verification
Chung Chow Chan (Editor), Y. C. Lee (Editor), Herman Lam (Editor), Xue-Ming Zhang (Editor)
ISBN: 978-0-471-46371-9
Adobe E-Book
320 pages
April 2004
US $109.99 Purchase This E-Book

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Other Available Formats: Hardcover

  • Description
  • Table of Contents
  • Author Information
  • Reviews
Contributors.

Preface.

1. Overview of Pharmaceutical Product Development and Its Associated Quality System (C. Chan & E. Jensen).

2. Potency Method Validation (C. Chan).

3. Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products (Y. Lee).

4. Dissolution Method Validation (C. Chan, et al.).

5. Development and Validation of Automated Methods (C. Incledon & H. Lam).

6. Analysis of Pharmaceutical Inactive Ingredients (X. Zhang).

7. Validation Study of JP Heavy Metal Limit Test (Y. Nishiyama).

8. Bioanalytical Method Validation (F. Garofolo).

9. Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview (H. Lam).

10. Performance Verification of UV-Vis Spectrophotometers (H. Lam).

11. Performance Verification of  HPLC (H. Lam).

12. Operational Qualification of a Capillary Electrophoresis Instrument (N. Baryla).

13. LC-MS Instrument Calibration (F. Garofolo).

14. Karl Fisher Apparatus and Its Performance Verification (R. Jairam, et al.).

15. The pH Meter and Its Performance Verification (Y. Tse, et al.).

16. Qualification of Environmental Chambers (G. Wong & H. Lam).

17. Equipment Qualification and Computer System Validation (L. Huber).

18. Validation of Excel Spreadsheet (H. Brunner).

Index.

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