Standard Operating Procedure for Disintegration Time Testing Method Development in Analytical Method Development
| Department | Analytical Method Development |
|---|---|
| SOP No. | SOP/AMD/284/2025 |
| Supersedes | SOP/AMD/284/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 21/05/2025 |
| Effective Date | 23/05/2025 |
| Review Date | 21/05/2026 |
1. Purpose
To define a validated and standardized procedure for the development and execution of a disintegration time testing method for solid oral dosage forms
2. Scope
This SOP applies to the Analytical Method Development and Quality Control departments responsible for evaluating disintegration behavior of solid oral formulations during development, validation, and batch release testing.
3. Responsibilities
- QC Analyst: Performs disintegration test as per established procedure.
- Formulation Scientist: Provides specifications and formulation matrix.
- QA Executive: Reviews and approves method development and validation documents.
4. Accountability
The Head of Analytical Method Development is accountable for ensuring that the disintegration method complies with regulatory requirements and provides consistent, reproducible results.
5. Procedure
5.1 Apparatus
- Disintegration test apparatus compliant with USP <701> and Ph. Eur. 2.9.1
- Six transparent tubes with wire mesh at the bottom
- Thermostatic water bath maintained at 37 ± 0.5°C
5.2 Disintegration Media
- Distilled water or simulated gastric/intestinal fluid without enzymes
- Volume per vessel: 800–1000 mL
5.3 Sample Preparation
- Select 6 intact dosage units randomly from the batch.
- Place one unit in each tube of the apparatus.
5.4 Test Execution
- Start apparatus and record the time at which all dosage units have disintegrated completely (no residue except fragments of insoluble coating or shell).
- If 1 or 2 units fail to disintegrate, repeat the test with another 12 units.
5.5 Acceptance Criteria
- Uncoated tablets: NMT 15 minutes
- Film-coated tablets: NMT 30 minutes
- Capsules: NMT 30 minutes
- Dispersible tablets: NMT 3 minutes
- Comply if 16 out of 18 units pass.
5.6 Validation Parameters
- Precision: Test repeated by two analysts on separate days; difference in average time should be ≤10%
- Robustness: Evaluate slight changes in media temperature and volume
- Specificity: Must differentiate intact from disintegrated dosage units
6. Abbreviations
- USP: United States Pharmacopeia
- Ph. Eur.: European Pharmacopoeia
- QA: Quality Assurance
- NMT: Not More Than
7. Documents
- Disintegration Test Log – Annexure-1
- Validation Summary Sheet – Annexure-2
8. References
- USP <701>: Disintegration
- Ph. Eur. 2.9.1: Disintegration of Tablets and Capsules
- ICH Q2(R1): Validation of Analytical Procedures
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Sanjana Iyer | Ravindra Joshi | Sunita Reddy |
| Designation | QC Officer | QA Reviewer | Head – AMD |
| Department | Analytical Method Development | QA | Analytical Method Development |
11. Annexures
Annexure-1: Disintegration Test Log
| Sample ID | Dosage Form | Time (min) | Medium | Status |
|---|---|---|---|---|
| DT-284-01 | Tablet | 11.5 | Water | Pass |
Annexure-2: Validation Summary
The disintegration method for tablets and capsules was validated. All results demonstrated acceptable reproducibility, specificity, and robustness. Method approved for batch release and formulation screening.
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 21/05/2025 | 2.0 | Expanded scope for dispersible tablets; updated validation strategy | Annual Review | Sunita Reddy |
| 12/07/2022 | 1.0 | Initial SOP Release | New SOP | QA Head |