Standard Operating Procedure for Preparing API-Excipient Compatibility Studies
1) Purpose
The purpose of this SOP is to provide guidelines for conducting compatibility studies between active pharmaceutical ingredients (APIs) and excipients used in nasal formulations, ensuring stability and safety.
2) Scope
This SOP applies to all personnel involved in formulating and testing API-excipient combinations at [Company Name].
3) Responsibilities
- Operators: Responsible for preparing the study samples and conducting the necessary tests.
- QA: Ensures that compatibility studies are performed accurately and reviewed for quality assurance.
4) Procedure
4.1 Selection of Excipients
4.1.1 Common Excipients for Compatibility Studies
- Select commonly used excipients such as preservatives, buffering agents, and stabilizers for compatibility testing with the API.
4.2 Preparation of Compatibility Samples
4.2.1 Sample Preparation
- Mix the API with individual excipients or combinations thereof in different ratios to create samples for compatibility testing.
- Record the amounts of API and excipients used for each sample in the study log.
4.3 Testing Procedures
4.3.1 Physical Stability Testing
- Monitor for any physical changes (e.g., color, texture, phase separation) in the samples over time.
4.3.2 Chemical Stability Testing
- Use high-performance liquid chromatography (HPLC) to analyze the chemical stability of
API-excipient combinations.
Compare the results with the control sample to ensure no significant degradation.
4.4 Documentation
- Document the results of the compatibility study in the API-Excipient Compatibility Study Log.
- Ensure QA reviews and approves the final compatibility results.
5) Abbreviations, if any
- API: Active Pharmaceutical Ingredient
- HPLC: High-Performance Liquid Chromatography
- QA: Quality Assurance
6) Documents, if any
- API-Excipient Compatibility Study Log
7) References, if any
- ICH Q1A – Stability Testing of New Drug Substances and Products
8) SOP Version
Version 1.0
Annexure
API-Excipient Compatibility Study Log Template
| Date | API | Excipient | Ratio | Stability Observations | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | API Name | Excipient Name | Ratio (e.g., 1:1) | Observations | Operator Name | QA Name |
