Standard Operating Procedure for Residual Solvent Testing in Transdermal Patches

1) Purpose

To establish procedures for testing residual solvents in transdermal patches to ensure compliance with safety and regulatory requirements.

2) Scope

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

3) Responsibilities

3.1 Quality Control Analyst: Perform residual solvent 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 Prepare samples by appropriate methods such as extraction or dilution.

4.2 Testing Method:

4.2.1 Perform residual solvent analysis using validated analytical techniques (e.g., gas chromatography).

4.2.2 Ensure testing conditions (e.g., temperature, calibration) are in accordance with method requirements.

4.3 Data Analysis:

4.3.1 Analyze test results to quantify residual solvent levels in transdermal patches.

4.3.2 Compare results against established acceptance criteria and regulatory limits.

4.4