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CHROMATOGRAPHIC METHODS VALIDATION

PROTOCOL EXAMPLE-TEMPLATE

PURPOSE

This example-template is designed to provide a ready to use, fill in form for a chromatographic methods validation protocol. The example-template is a comprehensive document which should be modified to meet the requirements of the particular validation.

SCOPE

This example-template protocol is applicable to any analytical laboratory which is involved in the research, development and validation of chromatographic methods which will be used to ensure the identity and measure the strength, quality, purity, and potency of active pharmaceutical ingredients and drug products. This protocol is in alignment with current industry practice and current ICH and FDA guidelines.

CONTENTS

This example-template protocol contains the following sections:

1. Study Description
2. Reference Materials
3. Safety Precautions
4. Method Validation analytical performance characteristics evaluations and testing required for

    validation including:

      a. Accuracy (Recovery)
      b. Precision (2 parts):
          i. Repeatability (Method Precision)
          ii. Intermediate Precision
      c. Specificity
      d. Detection Limit
      e. Quantitation Limit
      f. Linearity
      g. Range
      h. Robustness Testing
      i. System Suitability Determination
      j. Forced Degradation Studies
      k. Solution Stability Studies
      l. Filter Retention Studies
      m. Extraction Efficiency Studies

5. Reporting Requirements
6. Maintenance of Raw Data
7. References
8. Revision Summary

Descriptions, detailed procedures (including example sample preparation schemes) and recommended acceptance criteria are given for each section. Performance characteristics may be deleted if not applicable to the particular validation.

COST

The example-template is a 20 page protocol in MS Word® format available on CD for $49.95 plus $5.00 for shipping and handling.

ORDERING INFORMATION

Example-template is available for purchase on Delphi Analytical Services, Inc.’s website www.delphianalytical.com . Look under product purchase and choose either e-mail or fax purchase, or contact:

Marketing and Communications Department
Delphi Analytical Services, Inc.
P.O. Box 487
Indian Rocks Beach, FL 33785
Phone 727-642-0192
Fax 727-593-3595

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