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 to ensure reproducibility.
4.4 Interpretation of Results:
4.4.1 Compare sedimentation volume results against acceptance criteria specified in pharmacopeial standards or internal specifications.
4.4.2 Document sedimentation volume testing results accurately, including any deviations from expected values.
4.4.3 Investigate and resolve discrepancies or out-of-specification results promptly.
4.5 Acceptance Criteria:
4.5.1 Suspensions are considered acceptable if they demonstrate minimal sedimentation volume within specified limits.
4.5.2 Ensure all sedimentation volume measurements adhere to validated procedures and method validation parameters.
4.6 Documentation:
4.6.1 Record all sedimentation volume testing procedures, results, and observations in the Sedimentation Volume Testing Report.
4.6.2 Maintain detailed records of sample details, testing conditions, equipment calibration, and any corrective actions taken.
4.6.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Sedimentation Volume Testing Report
Sampling Plan Document
Equipment Calibration Certificates
7) Reference, if any
USP General Chapter <1160> – Pharmaceutical Calculations in Prescription Compounding
Pharmacopeial standards for Sedimentation Volume Testing in Suspensions
8) SOP Version
Version 1.0
