Elixir Department: SOP for Stability Indicating Testing – V 2.0

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Elixir Department: SOP for Stability Indicating Testing – V 2.0

Standard Operating Procedure for Stability Indicating Testing of Elixir Formulations

Department Elixir Department
SOP No. SOP/ELX/235/2025
Supersedes SOP/ELX/235/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for conducting stability indicating testing of elixir formulations to monitor the active pharmaceutical ingredient (API) content and degradation profile under defined storage conditions over time, ensuring product quality and shelf-life validity.

2. Scope

This SOP is applicable to the Quality Control and Stability Testing Departments for performing stability-indicating assays of elixir formulations during product development, registration, and routine stability studies.

3. Responsibilities

  • QC Analyst:
    • Perform analytical testing using validated stability-indicating methods and record data accurately.
  • Stability Coordinator:
    • Ensure samples are pulled and tested as per the approved stability protocol and schedule.
  • QA Officer:
    • Review the results and confirm adherence to specifications and regulatory requirements.

4. Accountability

The QC Head is accountable for ensuring proper execution of stability-indicating testing. The QA Head is responsible for compliance with ICH, WHO, and GMP guidelines.

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5. Procedure

5.1 Stability Protocol

  1. Follow the approved stability protocol for storage conditions, time points, and test parameters.
  2. Storage conditions:
    • 25°C ± 2°C / 60% RH ± 5% RH – Long-term
    • 30°C ± 2°C / 65% RH ± 5% RH – Intermediate (if applicable)
    • 40°C ± 2°C / 75% RH ± 5% RH – Accelerated
  3. Ensure containers are sealed and labeled appropriately to prevent mix-ups or contamination.

5.2 Analytical Method

  1. Use a validated stability-indicating HPLC or UPLC method capable of separating degradation products from the main peak.
  2. Ensure the method has been proven for specificity, accuracy, precision, linearity, and robustness as per ICH Q2(R1).
  3. Use impurity-spiked samples and stressed samples (acid/base/oxidative/photo/hydrolytic) to validate specificity.

5.3 Sampling and Testing Intervals

  1. Sample and test at intervals: 0, 1, 3, 6, 9, 12, 18, and 24 months for long-term; and 0, 3, and 6 months for accelerated conditions.
  2. Pull samples 2–5 days in advance of the due date to accommodate testing timelines.
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5.4 Parameters to Monitor

  • Assay of API (label claim retention)
  • Impurities and degradation products
  • pH, color, clarity, viscosity
  • Preservative content and alcohol strength (if applicable)
  • Microbial contamination (if required)

5.5 Data Interpretation

  1. Plot assay and impurity trends across time points.
  2. Assess changes in API content against acceptance limits (e.g., 90–110% of label claim unless otherwise justified).
  3. Compare results with release specifications and flag deviations or out-of-trend results.

5.6 Stability Conclusion

  1. Compile data in a stability summary sheet for submission or archival.
  2. If significant degradation is observed, initiate a deviation and investigate root causes.

5.7 Documentation

  1. Document results in the Stability Indicating Testing Logbook (Annexure-1).
  2. Attach raw data, chromatograms, and calculations with analyst initials and date.
  3. Ensure QA review and approval before finalizing reports.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • API: Active Pharmaceutical Ingredient
  • HPLC: High Performance Liquid Chromatography
  • UPLC: Ultra Performance Liquid Chromatography
  • QA: Quality Assurance
  • QC: Quality Control
  • ICH: International Council for Harmonisation
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7. Documents

  1. Stability Indicating Testing Logbook (Annexure-1)
  2. Stability Protocol and Schedule
  3. Validated Analytical Method SOP

8. References

  • ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
  • ICH Q2(R1) – Validation of Analytical Procedures
  • USP General Chapter <1225> – Validation of Compendial Procedures

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Stability Indicating Testing Logbook

Date Batch No. Storage Condition Time Point Assay (%) Total Impurities (%) pH Tested By Verified By
11/04/2025 ELX-0425-052 40°C / 75% RH 3 Months 96.2% 0.35% 5.7 Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP Creation QA Head
11/04/2025 2.0 Included new sampling conditions and impurity profiling ICH Compliance QA Head
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