SOP Guide for Pharma

Tablets: SOP for pH Stability Testing for Enteric-Coated Tablets – V 2.0

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Tablets: SOP for pH Stability Testing for Enteric-Coated Tablets – V 2.0

Standard Operating Procedure for pH Stability Testing for Enteric-Coated Tablets

Department Tablet
SOP No. SOP/TAB/081/2025
Supersedes SOP/TAB/081/2022
Page No. Page 1 of 7
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To establish a procedure for pH stability testing of enteric-coated tablets, ensuring that the tablets maintain their intended performance and dissolution characteristics across a range of pH values over time.

2. Scope

This SOP applies to the pH stability testing of enteric-coated tablets to evaluate their ability to resist dissolution under acidic conditions and to ensure they release the active pharmaceutical ingredient (API) in the appropriate pH environment.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that pH stability testing is performed as per this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.

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5. Procedure

5.1 Sample Collection

  1. Collect a representative sample of enteric-coated 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 visible contamination.
  4. Label the sample appropriately for identification during testing.

5.2 Preparation of pH Stability Test Apparatus

  1. Prepare a pH stability testing setup, including a pH meter, dissolution apparatus, and appropriate buffers.
  2. Prepare the dissolution media according to the test method, which should include a buffer solution at a pH of 1.2 (simulating stomach conditions) and a buffer solution at a pH of 6.8 (simulating intestinal conditions).
  3. Ensure that the dissolution apparatus is calibrated and that the test vessels are properly cleaned and maintained.

5.3 Conducting the pH Stability Test

  1. Place each tablet into the dissolution vessels and immerse in the pH 1.2 buffer solution at 37°C for the specified duration (usually 2 hours).
  2. After the specified time, transfer the tablets to the pH 6.8 buffer solution and continue the testing for the designated period (typically 4 hours).
  3. Monitor the dissolution process, ensuring the tablets remain intact under acidic conditions and begin to disintegrate or release API once the pH shifts to 6.8.
  4. At predefined intervals, sample the dissolution medium and analyze for the release of the active pharmaceutical ingredient (API) using an appropriate analytical method (e.g., UV spectrophotometry, HPLC).
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5.4 Data Recording and Calculation

  1. Record the pH stability testing results, including the time points and corresponding API concentrations, in the batch record (Annexure-1).
  2. Calculate the cumulative percentage of the API released at each time point, ensuring the release profile meets the specifications.
  3. Ensure that the tablets pass the dissolution criteria, which typically includes ≥ 80% of the API released in the pH 6.8 medium.

5.5 pH Stability Acceptance Criteria

  1. Ensure that the enteric-coated tablets do not disintegrate in the acidic pH (1.2), and that they release the API only after being exposed to the pH 6.8 buffer.
  2. If any tablet fails to meet the stability criteria, 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 the pH stability testing results, including the individual API release values and cumulative release, in the batch record (Annexure-1).
  2. Record any deviations from the pH stability specifications in the deviation report (Annexure-2), along with the corrective actions taken.
  3. Ensure that 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 all equipment used for pH stability testing, including dissolution vessels and pH meters, according to the manufacturer’s guidelines and the company’s cleaning SOP.
  2. Ensure that all equipment is properly stored and maintained in good working condition for future use.
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6. Abbreviations

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 Time Points (min) API Concentration (mg/mL) Cumulative Release (%)
Batch 001 6 tablets 30 2.5 50%
Batch 001 6 tablets 60 5.0 90%

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
12/11/2025 Batch 001 API release out of specification Re-formulated enteric coating John Doe

Revision History:

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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 pH Testing Protocols Improved test parameters for stability QA Head
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