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
- Manufacturing Personnel: Responsible for providing the required samples of film-coated tablets for dissolution testing.
- Quality Control (QC): Responsible for conducting dissolution tests, recording results, and ensuring compliance with the specified release criteria.
- Quality Assurance (QA): Ensures that dissolution testing is performed in compliance with this SOP and approves the final batch for release.
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
- Collect a representative sample of film-coated tablets from the batch as specified in the batch record.
- Ensure that the sample is properly labeled and stored in conditions suitable for dissolution testing.
- Ensure that the tablet sample is free from any physical defects, including cracks or chips that could affect dissolution testing.
5.2 Setup Dissolution Apparatus
- Verify that the dissolution apparatus is clean, calibrated, and functioning correctly as per the manufacturer’s instructions.
- 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.
- Confirm that the proper dissolution vessel type and paddle/rate setting are selected as per the tablet specifications.
5.3 Conduct Dissolution Test
- 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.
- Start the dissolution apparatus and ensure that the rotation speed of the paddle is set as specified (usually 50–75 rpm).
- At predefined time intervals (e.g., 5, 10, 15, 30, 45, and 60 minutes), collect a sample of the dissolution medium from the vessel.
- 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
- 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).
- Calculate the cumulative percentage of the drug released at each time point based on the API concentration and the volume of the dissolution medium.
- Ensure that the cumulative release profile meets the specified dissolution specifications outlined in the batch record or the pharmacopeial monograph.
5.5 Dissolution Acceptance Criteria
- 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.
- 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
- Clean the dissolution apparatus according to the manufacturer’s guidelines and the company’s cleaning SOP.
- Ensure that all glassware and equipment used during the dissolution testing are thoroughly cleaned and stored appropriately.
5.7 Documentation and Record-Keeping
- 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).
- Record any deviations from the established dissolution specifications in the deviation report (Annexure-2), and include the corrective actions taken.
- Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <701> – Dissolution Test
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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 |