SOP Guide for Pharma

Tablets: SOP for Dissolution Testing of Film-Coated Tablets – V 2.0

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Tablets: SOP for Dissolution Testing of Film-Coated Tablets – V 2.0

Standard Operating Procedure for Dissolution Testing of Film-Coated Tablets

Department Tablet
SOP No. SOP/TAB/072/2025
Supersedes SOP/TAB/072/2022
Page No. Page 1 of 6
Issue Date 10/02/2026
Effective Date 15/02/2026
Review Date 10/02/2027

1. Purpose

To provide a standardized method for conducting dissolution testing of film-coated tablets, ensuring that the tablets release their active pharmaceutical ingredient (API) in a controlled and predictable manner.

2. Scope

This SOP applies to the dissolution testing of film-coated tablets intended for oral administration, as part of the quality control process to assess tablet release characteristics.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the dissolution testing is performed according to this SOP and that results are properly documented. The QA Manager is responsible for reviewing and approving the final results.

5. Procedure

5.1 Sample Preparation

  1. Collect a representative sample of film-coated tablets from the batch as specified in the batch record.
  2. Ensure that the sample is properly labeled and stored in conditions suitable for dissolution testing.
  3. Ensure that the tablet sample is free from any physical defects, including cracks or chips that could affect dissolution testing.
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5.2 Setup Dissolution Apparatus

  1. Verify that the dissolution apparatus is clean, calibrated, and functioning correctly as per the manufacturer’s instructions.
  2. Ensure the apparatus is set to the correct temperature (usually 37°C) and that the dissolution medium (e.g., 0.1N HCl or phosphate buffer) is prepared according to the method specified in the batch record or USP monograph.
  3. Confirm that the proper dissolution vessel type and paddle/rate setting are selected as per the tablet specifications.

5.3 Conduct Dissolution Test

  1. Place the appropriate number of tablets in the dissolution vessel. Typically, 6 tablets per vessel are used, but this may vary according to the test method.
  2. Start the dissolution apparatus and ensure that the rotation speed of the paddle is set as specified (usually 50–75 rpm).
  3. At predefined time intervals (e.g., 5, 10, 15, 30, 45, and 60 minutes), collect a sample of the dissolution medium from the vessel.
  4. Filter the sample if required and measure the concentration of the dissolved API using a suitable analytical method (e.g., UV spectrophotometry, HPLC).

5.4 Data Recording and Calculation

  1. Record the time points at which samples were taken, the volume of the samples, and the analytical results (API concentration) for each time point in the batch record (Annexure-1).
  2. Calculate the cumulative percentage of the drug released at each time point based on the API concentration and the volume of the dissolution medium.
  3. Ensure that the cumulative release profile meets the specified dissolution specifications outlined in the batch record or the pharmacopeial monograph.
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5.5 Dissolution Acceptance Criteria

  1. Ensure that the dissolution profile meets the established criteria, typically ≥ 80% of the API should be released within 30 minutes for immediate release tablets, but this may vary based on the product.
  2. If the dissolution criteria are not met, investigate the cause and document the findings in the deviation report (Annexure-2). Consider reworking the batch or rejecting it if necessary.

5.6 Post-Test Cleanup and Maintenance

  1. Clean the dissolution apparatus according to the manufacturer’s guidelines and the company’s cleaning SOP.
  2. Ensure that all glassware and equipment used during the dissolution testing are thoroughly cleaned and stored appropriately.

5.7 Documentation and Record-Keeping

  1. Document all dissolution test results, including the sample identification, dissolution time points, measured API concentration, and cumulative release percentages, in the batch record (Annexure-1).
  2. Record any deviations from the established dissolution specifications in the deviation report (Annexure-2), and include 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.
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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 Time Points (min) API Concentration (mg/mL) Cumulative Release (%)
Batch 001 5 2.0 40%
Batch 001 10 3.5 70%
Batch 001 15 4.7 94%

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
12/12/2025 Batch 001 API release below specification Recalibrated dissolution apparatus Jane Smith

Revision History:

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 Improved Testing Process QA Head
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