Control Team: To conduct oxygen stability tests as per the protocol and document results.

R&D Team: To design the oxygen stability study protocol and provide technical support.

Regulatory Affairs Team: To ensure compliance with regulatory guidelines during oxygen exposure testing.

Stability Study

“Future of Drug Stability: How Pharmaceutical Stress Testing Safeguards Against Degradation and Ensures Medication Efficacy”

Coordinator: To manage testing schedules, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for evaluating the impact of oxygen on drug stability is outlined below:

1. Preparation of Oxygen Stability Study Protocol:
1. 4.1 Define the purpose, scope, and objective of the oxygen exposure study.
2. 4.2 Identify the drug product and critical quality attributes (CQAs) to be monitored (e.g., potency, degradation products, color).
3. 4.3 Determine the oxygen conditions to be tested (e.g., ambient air, controlled oxygen levels).
4. 4.4 Establish the time points for testing under each oxygen exposure condition (e.g., 0, 1, 3, 6 months).
5. 4.5 Develop a protocol outlining procedures, equipment, and materials required for testing.
2. Sample Preparation and Storage:
1. 4.6 Select representative samples of the drug product for testing.
2. 4.7 Package samples in containers that allow controlled oxygen exposure.
3. 4.8 Expose samples to specified oxygen conditions in a controlled environment.
3. Testing and Monitoring:
1. 4.9 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, dissolution).
2. 4.10 Record all test results in an oxygen stability testing log sheet.
3. 4.11 Evaluate the results against predefined acceptance criteria.
4. Data Analysis and Interpretation:
1. 4.12 Analyze the data to identify any trends or deviations due to oxygen exposure.
2. 4.13 Determine the impact of oxygen on the stability of the drug product.
3. 4.14 Document any significant findings or trends in the data.
5. Documentation and Reporting:
1. 4.15 Compile a comprehensive oxygen stability study report including objectives, methods, results, and conclusions.
2. 4.16 Ensure the report is reviewed and approved by relevant stakeholders.
3. 4.17 Submit the report to regulatory bodies or internal stakeholders as required.
6. Review and Update:
1. 4.18 Regularly review the oxygen stability study protocol and update it based on new data or regulatory changes.
2. 4.19 Archive the approved protocol and report in a controlled document management system.

5) Abbreviations, if any

• CQA: Critical Quality Attribute

6) Documents, if any

• Oxygen Stability Study Protocol
• Oxygen Stability Testing Log Sheets
• Oxygen Stability Study Report Template

7) Reference, if any

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0