Standard Operating Procedure for Identification Testing of Active Ingredients in Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/097/2025 |
| Supersedes | SOP/TAB/097/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for identification testing of active ingredients in tablets, ensuring that the correct active pharmaceutical ingredient (API) is present in the tablets and that the drug is compliant with product specifications.
2. Scope
This SOP applies to the identification testing of active ingredients in tablet formulations, including the use of appropriate analytical methods such as UV spectrophotometry, HPLC, or FTIR to confirm the presence of the API.
3. Responsibilities
- Quality Control (QC): Responsible for conducting the identification testing of active ingredients in tablets and ensuring that the results meet the required specifications.
- Quality Assurance (QA): Responsible for reviewing and approving the identification test results to ensure compliance with regulatory requirements and product specifications.
- Laboratory Personnel: Responsible for the preparation of samples, calibration of instruments, and execution of the identification test according to the established methods.
4. Accountability
The QC Manager is accountable for ensuring the accurate execution of identification testing in accordance with this SOP. 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 tablets from the batch, ensuring that the sample size meets the requirements specified in the batch record or pharmacopeial guidelines (usually a minimum of 6 tablets).
- Ensure that the tablets are free from visible defects such as cracks, chips, or discoloration that could interfere with the testing process.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Testing Apparatus
- Ensure that all laboratory equipment, such as balances, UV spectrophotometers, HPLC systems, or FTIR devices, are calibrated and functioning properly.
- Prepare any reagents or solvents required for the identification test as per the test method outlined in the batch record or pharmacopeial guidelines.
- Ensure that the test environment (e.g., temperature, humidity) is controlled as per the specifications for the chosen analytical method.
5.3 Performing Identification Test
- For UV spectrophotometry: Dissolve a specified number of tablets in a suitable solvent, filter the solution if necessary, and measure the absorbance at the wavelength specific to the API.
- For HPLC: Prepare a sample solution of the tablet, inject it into the HPLC system, and record the chromatogram. Compare the retention time and peak shape with those of a known standard of the API.
- For FTIR: Prepare a sample of the tablet, dissolve it if necessary, and record the infrared spectrum. Compare the spectrum with the standard fingerprint of the API.
- Ensure that the identification test confirms the presence of the API in the tablet and that the spectral or chromatographic characteristics match the expected values for the active ingredient.
5.4 Data Recording and Calculation
- Record the test results, including any chromatograms, spectra, or absorbance data, in the batch record (Annexure-1).
- Ensure that the identification test results comply with the specifications for the API, such as the correct retention time, absorption maxima, or spectral peaks.
- If the test results match the expected identification criteria, consider the sample compliant. If the results do not match, investigate and document the findings in the deviation report (Annexure-2).
5.5 Acceptance Criteria
- The identification test should confirm the presence of the API in the tablet. The results should match the expected values for the chosen analytical method (e.g., retention time, absorbance maxima, or spectral peaks).
- If the identification test fails, investigate and document the findings. Additional tests or sample retesting may be required to resolve any discrepancies.
5.6 Documentation and Record-Keeping
- Document all test results, including chromatograms, spectra, absorbance data, and calculations, 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 raw data, test results, and supporting documentation for future reference and audits.
5.7 Post-Test Cleanup
- Clean all equipment used for the identification test, including sample containers, balances, and instruments, according to the cleaning SOP to prevent contamination between tests.
- Ensure that all testing 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
- HPLC: High-Performance Liquid Chromatography
- UV: Ultraviolet
- FTIR: Fourier Transform Infrared Spectroscopy
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <711> – Dissolution Testing
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Identification 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 | Test Method | Result | Remarks |
|---|---|---|---|---|
| Batch 001 | Tablet Sample | HPLC | Pass | API identified correctly |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 12/12/2025 | Batch 001 | API not identified | Resample and retest using alternate method | 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 Test Methods | Refined testing procedure | QA Head |