SOP for Preparing API-Excipient Compatibility Studies

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