StabilityStudies.in

SOP for Assessing the Stability of Chiral Drugs

Standard Operating Procedure for Stability Testing of Chiral Drugs

1) Purpose

The purpose of this SOP is to provide a standard procedure for assessing the stability of chiral drugs. Stability studies for chiral drugs are essential to ensure that the enantiomeric purity and pharmacological activity are maintained throughout the product’s shelf life.

2) Scope

This SOP applies to all chiral drug substances and products manufactured, tested, or stored within the facility. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing using chiral analytical methods

such as chiral HPLC and GC.

Quality Assurance (QA) Team: Reviews and approves the stability study protocol and final reports.

Production Team: Provides samples and ensures documentation of batch records.

4) Procedure

Sample Preparation
1. Obtain representative samples of the chiral drug from production
  “Unlocking the Secrets of Pharmaceutical Preservation: Delving Into the Fascinating Realm of Chemical Stability in Pharmaceuticals!”
  batches.
2. Store samples under appropriate conditions until stability testing begins.
Development of Stability Study Protocol
1. Draft a protocol detailing the storage conditions, test intervals, and analytical methods (e.g., chiral HPLC, chiral GC).
2. Submit the protocol for approval by the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under defined conditions (e.g., 25°C/60% RH).
2. Perform stability tests at each specified interval to evaluate enantiomeric purity, potency, and degradation.
3. Document all observations, test results, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to determine any changes in the enantiomeric composition or pharmacological activity over time.
2. Prepare a comprehensive stability study report and submit it to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
GC: Gas Chromatography
RH: Relative Humidity

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
FDA Guidance for Industry: Development of New Stereoisomeric Drugs

8) SOP Version

Version 1.0