Standard Operating Procedure for Release Rate Testing of Transdermal Patches

1) Purpose

The purpose of this SOP is to outline the procedure for conducting release rate testing of transdermal patches to ensure they meet the required release rate specifications.

2) Scope

This SOP applies to all release rate testing activities for transdermal patches manufactured within the facility, including sample preparation, testing, and documentation.

3) Responsibilities

The Quality Control Department is responsible for performing and documenting release rate tests as per this SOP. The QC Manager ensures compliance with the procedure and regulatory requirements.

4) Procedure

4.1 Sample Preparation

• 4.1.1 Select samples of transdermal patches from the production batch.
• 4.1.2 Condition the samples at 25°C and 60% RH for at least 24 hours before testing.
• 4.1.3 Label the samples with the batch number and date of preparation.
• 4.1.4 Document the sample details in the release rate testing logbook.

4.2 Testing Equipment

• 4.2.1 Ensure the dissolution test apparatus (e.g., USP Apparatus 5 or 6) is calibrated and in proper working condition.
• 4.2.2 Set up the equipment according to the manufacturer’s instructions.

4.3 Testing Procedures

• 4.3.1 Release Rate Measurement:
  • 4.3.1.1 Mount the transdermal patch onto a suitable support (e.g., a stainless steel disc or holder).
  • 4.3.1.2 Place the mounted patch in the dissolution vessel containing