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