Standard Operating Procedure for Dissolution Testing

1) Purpose

This SOP outlines the procedures for conducting dissolution testing on pharmaceutical products to assess drug release characteristics.

2) Scope

This SOP applies to dissolution testing of solid oral dosage forms, including tablets and capsules, manufactured in the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing dissolution testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the dissolution testing protocol and ensure all necessary materials and equipment are available (e.g., dissolution apparatus, media).
2. Verify the calibration and functionality of the dissolution apparatus.

4.2 Sample Collection and Preparation

1. Collect a representative sample of solid oral dosage forms according to sampling procedures.
2. Prepare individual units for testing by removing excess powder or granules (if applicable).
3. Ensure proper labeling and identification of samples.

4.3 Testing Procedure

1. Fill the dissolution vessels with appropriate dissolution media as per the testing protocol.
2. Place the dosage units into the dissolution apparatus according to specified conditions (e.g., rotation speed, temperature).
3. Run the dissolution test for the specified time duration.
4. Sample aliquots at defined time intervals and analyze for drug content using validated analytical methods (e.g., HPLC, UV-Vis spectroscopy).

4.4 Acceptance Criteria

1. Compare the dissolution profiles of the tested samples against the acceptance criteria specified in compendial standards or product specifications.
2. Ensure that the drug release meets specified requirements over the specified time periods.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a dissolution testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Dissolution Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <711> Dissolution, USP <724> Drug Release, European Pharmacopoeia (Ph. Eur.) 2.9.3 Dissolution Test for Solid Dosage Forms

8) SOP Version

Version 1.0