Elemental Impurity Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting elemental impurity testing during the analytical method development process, ensuring the identification and quantification of elemental impurities in pharmaceutical products.

2) Scope

This SOP applies to all personnel involved in elemental impurity testing for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in elemental impurity testing.

4) Procedure

1. Selection of Analytical Method:
   1. Select appropriate analytical method for elemental impurity testing based on method requirements and regulatory guidelines.
   2. Verify method suitability and performance characteristics.
2. Sample Preparation:
   1. Prepare samples according to method requirements, ensuring proper handling and storage.
   2. Determine appropriate digestion or extraction methods for elemental impurity analysis.
3. Instrumental Analysis:
   1. Perform elemental impurity analysis using validated analytical instruments and techniques.
   2. Optimize instrumental parameters for sensitivity and selectivity.
4. Data Analysis and Reporting:
   1. Analyze elemental impurity testing data to quantify impurities and assess compliance with regulatory limits.
   2. Document elemental impurity testing results and conclusions in a testing report.
5. Review and Approval:
   1. Review the testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the testing report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to elemental impurity testing in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Elemental Impurity Testing Report
• Sample Preparation Records
• Instrument Calibration and Maintenance Records
• Data Analysis and Results Documentation
• Review and Approval Records

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q3D: Elemental Impurities
• USP General Chapter Elemental Impurities – Limits

8) SOP Version

Version 1.0