SOP Guide for Pharma

Tablets: SOP for Related Substance Testing for Extended Release Tablets – V 2.0

Auditor

Tablets: SOP for Related Substance Testing for Extended Release Tablets – V 2.0

Standard Operating Procedure for Related Substance Testing for Extended Release Tablets

Department Tablet
SOP No. SOP/TAB/083/2025
Supersedes SOP/TAB/083/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for testing related substances in extended release tablets, ensuring that the content of related substances in the tablets is within the specified limits, thereby ensuring product quality and compliance with regulatory standards.

2. Scope

This SOP applies to the related substance testing of extended release tablets to evaluate impurities and degradation products in accordance with pharmacopeial guidelines and internal specifications.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that related substance testing is performed in compliance with this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.

See also  Tablets: SOP for Preventive Maintenance of Tablet Manufacturing Equipment - V 2.0

5. Procedure

5.1 Sample Collection

  1. Collect a representative sample of extended release tablets from the batch, as specified in the batch record.
  2. The sample should consist of 6 tablets (or as specified in the batch record or pharmacopeial guidelines).
  3. Ensure that the tablets are free from defects such as cracks, chips, or contamination.
  4. Label the sample appropriately for identification during testing.

5.2 Preparation of Testing Apparatus

  1. Ensure that the analytical equipment (e.g., HPLC or GC system) is calibrated and properly maintained according to the manufacturer’s instructions and company’s equipment maintenance SOP.
  2. Prepare the mobile phase, standards, and sample solutions in compliance with the pharmacopeial methods or validated methods as specified in the batch record.

5.3 Performing the Related Substance Test

  1. Weigh the appropriate amount of sample from the extended release tablets and prepare the sample solution according to the method outlined in the batch record or pharmacopeial guidelines.
  2. Inject the sample solution into the chromatograph (HPLC or GC) and run the analysis according to the specified conditions (e.g., column type, flow rate, detection wavelength, and temperature).
  3. Simultaneously run the standard solution under the same conditions for comparison of impurity peaks.

5.4 Data Recording and Calculation

  1. Record the results, including the retention time, peak area, and relative retention times of any related substances in the sample solution.
  2. Calculate the percentage of related substances using the area or height of the related substance peaks and compare the results to the total content of the active pharmaceutical ingredient (API).
  3. Ensure that the total content of related substances is within the acceptable limits as specified in the batch record, typically ≤ 0.5% for individual impurities and ≤ 1.0% for total impurities, but this may vary depending on the product specifications.
See also  Tablets: SOP for Core Hardness Testing for Sustained Release Tablets - V 2.0

5.5 Acceptance Criteria

  1. Ensure that the related substances do not exceed the limits specified in the pharmacopeia or batch record.
  2. If any impurity exceeds the specified limits, the batch should be investigated, and corrective actions should be documented in the deviation report (Annexure-2).

5.6 Documentation and Record-Keeping

  1. Document all related substance testing results, including chromatographic data and impurity calculations, in the batch record (Annexure-1).
  2. Record any deviations from the acceptance criteria in the deviation report (Annexure-2), along with the corrective actions taken.
  3. Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.7 Post-Test Cleanup

  1. Clean the analytical equipment (e.g., HPLC or GC system) according to the manufacturer’s instructions and the company’s cleaning SOP to avoid cross-contamination between tests.
  2. Ensure that all equipment is properly stored and maintained in good working condition for future use.

6. Abbreviations

See also  Tablets: SOP for Identification Testing of Active Ingredients in Tablets - V 2.0

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number Tablet Sample Impurity Type Impurity % Result
Batch 001 6 tablets Impurity A 0.2% Pass

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Impurity level exceeded specification Adjusted formulation process John Doe

Revision History:

You said:
Continue
ChatGPT said:
Here is the continuation of the SOP for “Related Substance Testing for Extended Release Tablets” in HTML format:

html
Copy

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated Testing Parameters and Methods Refined test methodology and impurity specifications QA Head
Exit mobile version