Standard Operating Procedure for Dissolution Testing of Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting dissolution testing of granules in the pharmaceutical industry to assess the release of active pharmaceutical ingredients (APIs) from granules under simulated physiological conditions.

2) Scope

This SOP applies to all personnel involved in dissolution testing of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Quality Control (QC) Analyst: Responsible for performing dissolution testing.
Production Supervisor: Responsible for overseeing the testing process and ensuring compliance.

4) Procedure

1. Equipment Setup:
   1. Verify the functionality and calibration status of the dissolution testing apparatus (e.g., dissolution tester).
   2. Prepare dissolution medium as per specified requirements (e.g., temperature, pH).
2. Sample Preparation:
   1. Prepare granule samples according to the prescribed method and batch specifications.
   2. Ensure proper labeling and identification of the samples.
3. Testing Process:
   1. Place the prepared granule samples into individual dissolution vessels containing the dissolution medium.
   2. Start the dissolution tester and allow the samples to dissolve under controlled conditions.
   3. Collect dissolution samples at specified time intervals.
4. Analysis and Interpretation:
   1. Analyze the collected dissolution samples for the concentration of the API using appropriate analytical methods (e.g., UV-Vis spectrophotometry).
   2. Plot dissolution profiles and calculate dissolution parameters such as dissolution rate and dissolution efficiency.
   3. Compare dissolution results with acceptance criteria specified in relevant pharmacopeial standards or internal protocols.
5. Cleaning and Maintenance:
   1. After testing, clean the dissolution tester and dissolution vessels thoroughly to prevent cross-contamination.
   2. Document cleaning and maintenance activities in the designated logbook.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
API: Active Pharmaceutical Ingredient

6) Documents, if any

Dissolution Testing Protocol, Dissolution Medium Preparation Records, Equipment Calibration Logs

7) Reference, if any

Pharmacopeial guidelines on dissolution testing of pharmaceutical dosage forms.

8) SOP Version

Version 1.0