Procedure for Sedimentation Volume Testing in Suspensions

1) Purpose

The purpose of this SOP is to outline the procedure for determining the sedimentation volume of pharmaceutical suspensions to assess stability and uniformity.

2) Scope

This SOP applies to all pharmaceutical suspensions manufactured within the facility that require sedimentation volume testing as part of quality control.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting sedimentation volume testing and ensuring compliance with this SOP.
Production Department: Responsible for providing suspension samples and supporting QC during testing.

4) Procedure

4.1 Sample Preparation:
    4.1.1 Obtain representative samples of suspensions from different batches.
    4.1.2 Homogenize the suspension thoroughly using a suitable method to ensure uniform distribution.
    4.1.3 Fill the suspension into graduated cylinders or similar transparent containers.

4.2 Sedimentation Process:
    4.2.1 Place the filled containers in a stable vertical position without disturbance.
    4.2.2 Allow the suspensions to sediment under controlled conditions (e.g., temperature) for a specified duration.
    4.2.3 Record the initial volume of the suspension and mark the sedimentation height on the container.

4.3 Volume Measurement:
    4.3.1 Measure the final volume of the supernatant liquid after sedimentation has completed.
    4.3.2 Calculate the sedimentation volume by subtracting the final volume from the initial volume.
    4.3.3 Perform measurements in triplicate