StabilityStudies.in

SOP for Assessing Stability for Polymorphic Drugs

Standard Operating Procedure for Stability Testing of Polymorphic Drug Substances

1) Purpose

The purpose of this SOP is to establish a procedure for assessing the stability of polymorphic drug substances, ensuring they retain their desired crystalline form, potency, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all polymorphic drug substances 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 polymorphic stability testing using methods such as X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC).
Quality Assurance

(QA) Team: Ensures protocol compliance and reviews final reports.

Production Team: Provides necessary samples and maintains proper documentation.

4) Procedure

Sample Preparation
1. Collect representative samples from batches known to contain the desired polymorphic form.
2. Store samples under appropriate conditions until the stability study
  “Unveiling the Secret of Drug Stability: Exploring Chemical Kinetics to Ensure Long-lasting Effectiveness and Safety”
  begins.
Design of Stability Study
1. Prepare a protocol detailing storage conditions, test intervals, and analytical methods (e.g., XRPD, DSC).
2. Submit the protocol for approval by the QA and Regulatory Affairs teams.
Execution of Stability Study
1. Store samples in stability chambers under controlled conditions (e.g., 25°C/60% RH).
2. Perform polymorphic stability tests at each specified interval to assess any changes in the crystalline form.
3. Document all observations, test results, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the data to detect any changes in polymorphic form or stability over time.
2. Prepare and submit a comprehensive report to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
XRPD: X-ray Powder Diffraction
DSC: Differential Scanning Calorimetry

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: ANDAs: Pharmaceutical Solid Polymorphism

8) SOP Version

Version 1.0