Procedure for Capsule Dissolution Testing

1) Purpose

The purpose of this SOP is to outline the procedure for testing the dissolution of capsules to ensure consistent release of the active pharmaceutical ingredient (API) over a specified time period.

2) Scope

This SOP applies to all capsule batches produced within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting dissolution testing and ensuring compliance with this SOP.
Production Department: Responsible for providing capsule samples for testing and maintaining process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Select a statistically valid number of capsules from the batch according to the sampling plan (e.g., 12 capsules).
    4.1.2 Ensure the capsules are randomly chosen to represent the entire batch.

4.2 Equipment Preparation:
    4.2.1 Set up the dissolution apparatus (e.g., USP apparatus) as per the manufacturer’s instructions.
    4.2.2 Ensure the apparatus is clean and calibrated.

4.3 Dissolution Testing Procedure:
    4.3.1 Fill each dissolution vessel with the specified dissolution medium (e.g., pH 6.8 phosphate buffer).
    4.3.2 Set the apparatus to the specified rotation speed (e.g., 50 rpm) and temperature (e.g., 37°C).
    4.3.3 Place one capsule in each vessel.
    4.3.4 Withdraw samples at specified time intervals (e.g., 15, 30, 45, and 60 minutes).
    4.3.5 Analyze the samples for API content using a suitable analytical method (e.g., HPLC).
    4.3.6 Calculate the percentage of API released over time.

4.4 Acceptance Criteria:
    4.4.1 The capsule batch is acceptable if the dissolution profile meets the specified criteria (e.g., at least 80% of API released within 45 minutes).

4.5 Documentation:
    4.5.1 Document all results, dissolution profiles, and calculations in the Capsule Dissolution Test Record.
    4.5.2 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography

6) Documents, if any

Capsule Dissolution Test Record
Calibration Record for Dissolution Apparatus
Sampling Plan Document

7) Reference, if any

USP <711> – Dissolution
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0