Aerosol: SOP for Conducting Assay Testing of Active Ingredients in Aerosols – V 2.0

Procedure for Assay Testing of Active Ingredients in Aerosol Products

Department	Aerosol
SOP No.	SOP/Aerosol/191/2025
Supersedes	SOP/Aerosol/191/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for conducting assay testing of active ingredients in aerosol products to ensure potency, consistency, and compliance with regulatory requirements.

2. Scope

This SOP applies to all aerosol formulations containing active pharmaceutical ingredients (APIs) and is applicable in the Quality Control (QC) laboratory.

3. Responsibilities

Quality Control (QC) Analysts: Responsible for performing the assay tests.
Quality Assurance (QA) Team: Responsible for reviewing and approving assay test reports.
Laboratory Supervisor: Responsible for overseeing test procedures and ensuring compliance.
Production Team: Responsible for providing representative samples for testing.

4. Accountability

The Quality Control Manager is accountable for ensuring assay tests are performed accurately and consistently.

5. Procedure

5.1. Sample Collection

Collect representative aerosol samples as per the approved sampling plan.
Label the samples with batch number, date, and analyst details.
Record sample collection details in the Sample Log (Annexure-1).

5.2. Preparation of Test Solutions

Weigh a precise amount of the aerosol sample.
Dissolve the active ingredient in an appropriate solvent.
Prepare a standard solution for comparison.
Document preparation details in the Test Preparation Log (Annexure-2).

5.3. Assay Testing

Procedure

Perform assay testing using a validated analytical method (e.g., HPLC, UV Spectroscopy).
Run the test in triplicate for accuracy.
Calculate the concentration of the active ingredient.
Record assay test results in the Assay Test Log (Annexure-3).

5.4. Data Analysis and Acceptance Criteria

Compare test results with specified limits (e.g., 95%–105% of label claim).
Ensure all test values fall within acceptable range.
Document findings in the Assay Results Report (Annexure-4).

5.5. Handling Out-of-Specification (OOS) Results

Initiate an investigation if results are out of specification.
Repeat testing as per standard OOS procedures.
Record investigation details in the OOS Report (Annexure-5).

6. Abbreviations

API: Active Pharmaceutical Ingredient
QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
UV: Ultraviolet Spectroscopy
OOS: Out of Specification

7. Documents

Sample Log (Annexure-1)
Test Preparation Log (Annexure-2)
Assay Test Log (Annexure-3)
Assay Results Report (Annexure-4)
OOS Report (Annexure-5)

8. References

Good Manufacturing Practice (GMP) Guidelines
Pharmacopeial Standards (USP/BP/IP)
FDA Guidelines on Analytical Method Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Log

Batch No.	Sample ID	Collection Date	Analyst
BN-220	SPL-101	07/02/2025	Rahul Mehta

Annexure-2: Test Preparation Log

Sample ID	Solvent Used	Concentration Prepared	Prepared By
SPL-101	Methanol	10 mg/mL	QA Team

Annexure-3: Assay Test Log

Sample ID	Method Used	Assay Result (%)	Tested By
SPL-101	HPLC	99.2%	QA Team

Annexure-4: Assay Results Report

Batch No.	Label Claim (%)	Test Result (%)	Approved By
BN-221	100%	99.2%	QA Team

Annexure-5: OOS Report

Batch No.	OOS Result	Investigation Status	Reviewed By
BN-222	92%	Under Investigation	QA Team

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma
01/01/2025	V 2.0	Updated assay procedures	GMP Compliance	Anjali Sharma