Procedure for Content Uniformity in Capsules

1) Purpose

The purpose of this SOP is to outline the procedure for testing content uniformity in filled capsules to ensure each capsule contains the correct amount of active pharmaceutical ingredient (API) within specified limits.

2) Scope

This SOP applies to all capsule formulations manufactured within the facility that require content uniformity testing as per regulatory requirements.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting content uniformity testing and ensuring compliance with this SOP.
Production Department: Responsible for providing capsule samples and supporting QC during testing.

4) Procedure

4.1 Sample Selection:
    4.1.1 Select representative samples of filled capsules from different batches.
    4.1.2 Ensure samples are taken randomly and cover the entire batch production.

4.2 Sample Preparation:
    4.2.1 Open capsules and disintegrate their contents to obtain a homogenous sample of API.
    4.2.2 Prepare sample solutions or suspensions as per validated methods and dilutions if necessary.
    4.2.3 Ensure samples are properly identified, labeled, and stored under appropriate conditions.

4.3 Content Uniformity Testing:
    4.3.1 Analyze individual capsules or sample solutions using validated analytical methods, such as HPLC or UV-Vis spectroscopy.
    4.3.2 Determine API content in each capsule or sample solution.
    4.3.3 Calculate the mean and relative standard deviation (RSD) of API