Standard Operating Procedure for Moisture Content Testing in Transdermal Patches

1) Purpose

To establish procedures for determining the moisture content in transdermal patches to ensure product stability and quality.

2) Scope

This SOP applies to the quality control department responsible for performing moisture content testing on transdermal patches during production.

3) Responsibilities

3.1 Quality Control Analyst: Perform moisture content testing according to defined procedures.
3.2 Production Supervisor: Provide samples for testing in accordance with sampling plans.
3.3 QA Personnel: Review and approve testing procedures and results.
3.4 Production Operators: Assist in sample collection and preparation for testing.

4) Procedure

4.1 Sample Preparation:

4.1.1 Obtain representative samples of transdermal patches from production batches.

4.1.2 Ensure samples are handled in controlled environmental conditions to prevent moisture absorption or loss.

4.2 Testing Method:

4.2.1 Determine the moisture content using validated analytical methods (e.g., Karl Fischer titration).

4.2.2 Calibrate and set up the moisture analyzer according to manufacturer’s instructions.

4.3 Data Analysis:

4.3.1 Perform moisture content analysis on prepared samples.

4.3.2 Calculate moisture content as a percentage based on weight loss or water content.