Standard Operating Procedure for Disintegration Testing for Immediate Release Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/075/2025 |
| Supersedes | SOP/TAB/075/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 25/02/2026 |
| Effective Date | 01/03/2026 |
| Review Date | 25/02/2027 |
1. Purpose
To outline the procedure for performing disintegration testing of immediate release tablets, ensuring that the tablets break down into smaller particles as required by pharmacopoeial standards.
2. Scope
This SOP applies to the disintegration testing of immediate release tablets to verify that they disintegrate within the specified time when tested under controlled conditions.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing representative samples of immediate release tablets for disintegration testing.
- Quality Control (QC): Responsible for conducting disintegration tests, recording results, and ensuring compliance with the specified limits in the batch record.
- Quality Assurance (QA): Ensures that the disintegration testing procedure is followed as per this SOP and reviews the results for batch release.
4. Accountability
The QC Manager is accountable for ensuring that the disintegration testing is carried out according to this SOP and for reporting the results. The QA Manager is responsible for reviewing the test results and approving the batch for release.
5.
Procedure
5.1 Sample Collection
- Collect a representative sample of immediate release tablets from the batch according to the batch record.
- The sample should consist of 6 tablets (or as specified in the batch record or pharmacopeial guidelines).
- Ensure that the tablets are free from defects such as chips, cracks, or visible contamination.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Disintegration Apparatus
- Ensure that the disintegration apparatus is clean and calibrated according to the manufacturer’s instructions.
- Set the disintegration apparatus to the correct test temperature, typically 37°C, and ensure that the disintegration medium (usually water or simulated gastric fluid) is at the proper temperature and volume.
- Ensure that the disintegration baskets and tubes are correctly assembled and positioned in the apparatus.
5.3 Conducting the Disintegration Test
- Place the tablets in the disintegration baskets and immerse them in the disintegration medium.
- Start the disintegration test and allow the tablets to undergo the test for the required period, typically 30 minutes.
- Ensure that the tablets disintegrate into smaller particles and that no intact tablets remain at the end of the test period.
- Observe the disintegration process closely and ensure that all tablets disintegrate within the specified time, as outlined in the batch record or pharmacopeial guidelines.
5.4 Recording the Results
- At the end of the test, record whether each tablet has disintegrated completely.
- If any tablet fails to disintegrate within the specified time, document this in the batch record (Annexure-1) and investigate the cause.
- Record the exact time of disintegration for each tablet, as well as any observations, such as incomplete disintegration or any foreign matter found in the disintegration medium.
5.5 Dissolution Acceptance Criteria
- Ensure that the tablets meet the disintegration test criteria, typically requiring that no tablet remains intact after 30 minutes, but the time may vary depending on the product.
- If any tablet does not meet the disintegration criteria, the batch should be investigated, and corrective actions should be documented in the deviation report (Annexure-2).
5.6 Documentation and Record-Keeping
- Document all disintegration test results, including the time at which each tablet disintegrated, in the batch record (Annexure-1).
- Record any deviations or failures in the deviation report (Annexure-2), along with the corrective actions taken.
- 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
- Clean the disintegration apparatus and all associated equipment according to the manufacturer’s instructions and the company’s cleaning SOP.
- Ensure that the equipment is properly stored and maintained to ensure continued accurate testing.
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> – Disintegration Test
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
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 of Disintegration (min) | Observations |
|---|---|---|---|
| Batch 001 | 6 tablets | 5 minutes | All tablets disintegrated fully |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Tablet failed disintegration test | Re-formulated tablet composition | John Doe |
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 Method | QA Head |