Standard Operating Procedure for Content Uniformity Testing of Immediate Release Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/093/2025 |
| Supersedes | SOP/TAB/093/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for content uniformity testing of immediate release tablets, ensuring that the active pharmaceutical ingredient (API) is consistently distributed within each tablet and meets the required specifications.
2. Scope
This SOP applies to content uniformity testing for immediate release tablets, including the preparation of the sample, testing procedure, and acceptance criteria to ensure consistent API distribution across all tablets.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing tablet samples for content uniformity testing and ensuring proper handling and storage of the tablets.
- Quality Control (QC): Responsible for conducting the content uniformity test, recording the results, and ensuring compliance with established specifications.
- Quality Assurance (QA): Ensures the testing procedure is followed correctly and reviews the results for batch approval and regulatory compliance.
4. Accountability
The QC Manager is accountable for ensuring that the content uniformity testing is conducted in compliance with this SOP. The QA Manager is responsible for reviewing the results and
approving the batch for release.
5. Procedure
5.1 Sample Collection
- Collect a representative sample of tablets from the batch. The sample should consist of a minimum of 30 tablets, or as specified in the batch record or pharmacopeial guidelines.
- Ensure that the tablets are free from defects such as cracks, chips, or contamination.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Sample
- Weigh a specified number of tablets (usually 10 tablets) and crush them into a fine powder using a clean mortar and pestle or a tablet grinder.
- Ensure that the tablet powder is homogeneous, with no visible clumps or aggregation.
- Accurately weigh an appropriate amount of the powder for dissolution in a suitable solvent or dissolution medium, following the test method outlined in the batch record or pharmacopeial guidelines.
5.3 Performing Content Uniformity Test
- Transfer the prepared sample into a suitable solvent or dissolution medium, ensuring complete dissolution of the tablet powder.
- Perform the assay of the API using a suitable analytical method, such as HPLC, UV spectrophotometry, or titration, depending on the characteristics of the API.
- Ensure that the sample is analyzed according to the pharmacopeial guidelines or internal testing protocols to determine the API content in each tablet.
5.4 Data Recording and Calculation
- Record the assay results for each tablet, including the concentration of the API and the calculated amount in each tablet (Annexure-1).
- Calculate the average API content of the tested tablets and the relative standard deviation (RSD) for the sample.
- Ensure that the individual tablet content does not vary by more than ±15% from the label claim (for 90% of the tablets tested) and that the average content is within 85%-115% of the label claim.
5.5 Acceptance Criteria
- Ensure that the content uniformity test results meet the following acceptance criteria:
- The content of 90% of the tablets must be within ±15% of the label claim.
- The average content of the tablets must be within 85%–115% of the label claim.
- If any tablet fails to meet the acceptance criteria, investigate and document the findings in the deviation report (Annexure-2).
- Take corrective actions as necessary and perform re-testing if required.
5.6 Documentation and Record-Keeping
- Document all test results, including the assay results, calculations, and observations, in the batch record (Annexure-1).
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
- Maintain all chromatograms, raw data, and assay results for future reference and audits.
5.7 Post-Test Cleanup
- Clean all equipment used for content uniformity testing, including sample containers, balances, and dissolution apparatus, according to the cleaning SOP to prevent contamination between tests.
- Ensure the laboratory equipment is properly maintained and calibrated for future use.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- RSD: Relative Standard Deviation
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <905> – Uniformity of Dosage Units
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Content Uniformity Testing
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 | Sample Weight (g) | API Content (%) | Result |
|---|---|---|---|---|
| Batch 001 | Tablet Sample | 0.5 | 99.3% | Pass |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 12/12/2025 | Batch 001 | API content variation in tablet samples | Adjusted blending process and rechecked formulation | 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 | Refined content uniformity protocols | QA Head |