is responsible for reviewing the results and approving the batch for release.

5. Procedure

5.1 Sample Collection

1. Collect a representative sample of sustained release tablets from the batch, as specified in the batch record.
2. The sample should consist of 6 tablets (or as specified in the batch record or pharmacopeial guidelines).
3. Ensure that the tablets are free from visible defects such as cracks, chips, or any other signs of damage.
4. Label the sample appropriately for identification during testing.

5.2 Preparation of Dissolution Apparatus

1. Ensure that the dissolution apparatus is clean and calibrated according to the manufacturer’s instructions.
2. Set the dissolution apparatus to the correct test temperature, typically 37°C (±0.5°C), and ensure that the dissolution medium (e.g., 0.1N HCl or phosphate buffer) is prepared according to the method specified in the batch record or pharmacopeial guidelines.
3. Ensure that the dissolution vessels and paddles or baskets are positioned correctly in the apparatus and are functioning properly.

5.3 Conducting the Dissolution Profile Test

1. Place the appropriate number of sustained release tablets in the dissolution vessels (typically 1 tablet per vessel).
2. Start the dissolution apparatus and ensure that the paddles or baskets rotate at the specified speed (usually 50–75 rpm).
3. At pre-specified time intervals (e.g., 15, 30, 60, 120, 180, 240 minutes), collect a sample of the dissolution medium from each vessel.
4. Ensure that the samples are filtered if necessary and are analyzed using an appropriate analytical method (e.g., UV spectrophotometry or HPLC) to measure the concentration of the API in each sample.

5.4 Data Recording and Calculation

1. Record the results of the dissolution profile, including the time points and the corresponding API concentrations, in the batch record (Annexure-1).
2. Calculate the cumulative percentage of the API released at each time point based on the concentration data and the volume of dissolution medium used.
3. Ensure that the dissolution profile meets the specified criteria, typically ≥ 80% of the API released within 12 hours, but this may vary depending on the product and its specifications.

5.5 Dissolution Acceptance Criteria

1. Ensure that the dissolution profile meets the required specifications outlined in the batch record, which may include a specific percentage of the API released at specified time points (e.g., 50% released in 1 hour, 80% released in 6 hours, etc.).
2. If the dissolution profile does not meet the acceptance criteria, the batch should be investigated, and corrective actions should be documented in the deviation report (Annexure-2).

5.6 Documentation and Record-Keeping

1. Document all dissolution profile testing results, including the time points and corresponding API concentrations, in the batch record (Annexure-1).
2. Record any deviations from the dissolution specifications in the deviation report (Annexure-2), along with the corrective actions taken.
3. 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

1. Clean the dissolution apparatus and all associated equipment after each test according to the manufacturer’s guidelines and the company’s cleaning SOP.
2. Ensure that all 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

1. Batch Record (Annexure-1)
2. Deviation Report (Annexure-2)

8. References

• USP <711> – 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	Tablet Sample	Time Points (min)	API Concentration (mg/mL)	Cumulative Release (%)
Batch 001	6 tablets	15	1.5	45%
Batch 001	6 tablets	30	3.0	75%
Batch 001	6 tablets	60	4.5	90%

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	API release below specification	Adjusted 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 Test Parameters	Improved Testing Process	QA Head