SOP Guide for Pharma

Creams: SOP for Dissolution Testing of Cream Products – V 2.0

Auditor

Creams: SOP for Dissolution Testing of Cream Products – V 2.0

Standard Operating Procedure for Dissolution Testing of Cream Products

Department Creams
SOP No. SOP/CRM/147/2025
Supersedes SOP/CRM/147/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to outline the procedure for conducting dissolution testing of cream products. Dissolution testing is performed to evaluate the release rate of active ingredients from cream formulations. This SOP ensures that the creams meet the required specifications for the controlled release of active ingredients, which is crucial for product efficacy and safety.

2. Scope

This SOP applies to all cream formulations that require dissolution testing to assess the release of active ingredients. It covers the procedures for preparing cream samples, performing dissolution testing, and recording the results for quality control and regulatory purposes.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that dissolution testing is conducted in accordance with this SOP. The Production Supervisor is responsible for preparing the cream samples for dissolution testing. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.

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5. Procedure

5.1 Pre-Test Preparation

  1. Ensure that the necessary dissolution testing equipment is available, including dissolution apparatus (e.g., USP apparatus 2), temperature-controlled water bath, and calibrated pH meters.
  2. Review the batch record to confirm the formulation details and identify the active ingredients that need to be tested for dissolution.
  3. Prepare the cream samples according to the formulation and ensure they are properly homogenized and free from contamination.
  4. Label each sample with the batch number, sample ID, and test date for traceability during testing.

5.2 Dissolution Testing Procedure

  1. Set the dissolution apparatus to the required settings, including the specified temperature (typically 37°C ± 0.5°C) and appropriate rotation speed (typically 50-75 rpm).
  2. Place the cream sample into the dissolution vessel. If the cream is semi-solid, a small quantity should be carefully introduced to avoid disturbance during the test.
  3. Start the dissolution test by adding the required dissolution medium (e.g., phosphate buffer or water) to the vessel. Ensure that the medium is maintained at the correct volume and temperature throughout the test.
  4. At specified time intervals (e.g., 5, 10, 15, 30, 60 minutes), take aliquots from the dissolution medium for analysis of the active ingredient content.
  5. Ensure that the sample aliquots are properly filtered and analyzed using an appropriate analytical technique, such as HPLC or UV spectroscopy, to measure the active ingredient concentration in the dissolution medium.
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5.3 Data Analysis and Interpretation

  1. Calculate the percentage of active ingredient released at each time point. Compare the results with the established specifications for the cream formulation, which may include a required release profile over time.
  2. If the release rate meets the specified criteria, mark the test as “Pass” in the Dissolution Testing Log (Annexure-1) and proceed with the next stage of production or release.
  3. If the release rate does not meet the specified criteria, mark the test as “Fail.” Investigate the potential causes of failure, such as improper sample preparation, equipment malfunction, or formulation issues.

5.4 Post-Test Activities

  1. Record all results, including batch number, sample ID, test date, active ingredient concentrations, and any deviations from the specifications, in the Dissolution Testing Log (Annexure-1).
  2. If the dissolution test fails, initiate corrective actions, such as re-formulating the product, adjusting the dissolution medium, or modifying the manufacturing process.
  3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.5 Documentation and Record-Keeping

  1. Ensure that all dissolution testing records are complete, accurate, and securely stored. This includes the Dissolution Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
  2. Retain all records for a minimum of two years or as required by regulatory guidelines.
  3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.
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6. Abbreviations

7. Documents

  1. Annexure-1: Dissolution Testing Log
  2. Annexure-2: Deviation Log

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Dissolution Testing Log

Batch Number Sample ID Test Date Time (min) Release (%) Operator
12345 S-001 21/01/2026 10 25% John Doe
12345 S-001 21/01/2026 30 60% John Doe

Annexure-2: Deviation Log

Deviation Date Batch Number Deviation Description Corrective Action Taken Operator
21/01/2026 12345 Release rate below specification Reformulated batch and adjusted testing parameters Jane Smith

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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