Standard Operating Procedure for Assay of Active Ingredient in Aerosols

1) Purpose

The purpose of this SOP is to establish procedures for the assay of active pharmaceutical ingredients (APIs) in aerosol formulations. Assay testing ensures accurate determination of API content to meet regulatory requirements and product specifications.

2) Scope

This SOP applies to the assay testing activities performed at [Company Name] for aerosol products, including in-process and release testing of batches.

3) Responsibilities

Quality Control (QC) Analysts: Responsible for performing assay testing.
Formulation Scientists: Provide test samples and collaborate on testing protocols.
Quality Assurance (QA) Manager: Ensure compliance with testing procedures and documentation.

4) Procedure

4.1 Sample Preparation:
4.1.1 Obtain representative samples from the aerosol batch as per sampling plan.
4.1.2 Prepare samples according to specified procedures to ensure uniformity and integrity.

4.2 Assay Method:
4.2.1 Select appropriate assay method (e.g., HPLC, UV spectrophotometry) based on API properties and formulation matrix.
4.2.2 Validate assay method if not previously validated, ensuring specificity, accuracy, precision, linearity, and robustness.

4.3 Testing Protocol:
4.3.1 Perform assay testing according to validated method protocols.
4.3.2 Analyze samples in triplicate or as per method requirements to ensure reliable results.

4.4 Data Analysis:
4.4.1 Calculate API concentration in samples based on assay