Force Degradation Study (FDS) – A Comprehensive Guide
This article provided Comprehensive information on Force degradation Study (FDS), Methodology of testing, Why it is required in pharmaceutical industry.
Force Degradation Study (FDS) – A Comprehensive Guide
What is mean by Force Degradation Study (FDS) ?
Force degradation study in the pharmaceutical industry means intentional application of stress conditions such as Heat, Humidity, Light Acid/Base hydrolysis, Oxidation, PH, and Metal) to a drug substance or drug product to accelerate its degradation.
The purpose of force degradation is to identify and characterize degradation products and that may form impurities over a period of time under normal storage and use conditions.
Brief Summary and Methodology for Testing :
The experimental protocol for degradation studies should be prepared considering the chemistry between Drug substance and product
A Test Method is specific for the analyte, therefore non interference of known impurities degradation product and excipients should be demonstrate for quantification of main peak by force degradation study.
Preferably, following stress conditions are recommended for the specificity study, However stress condition can be decided based on experimental data or physical properties of Analyte moreover it is applicable as per the product nature.
- Heat Degradation
- Humidity Degradation
- Photolytic/Sunlight/UV Degradation
- Acid Degradation
- Base Degradation
- Peroxide Degradation
- Metallic Degradations
After stressing prepare the solution to a volume, to get the specified concentration with diluent as per test procedure. with that appropriate blank should be prepared in all degradation mediums.
If degradation media degrade the drug substances to great extent or degradation medium do not degrade the drug substances at all, In both case alternate action should be taken accordingly. (eg. : Increase/Decrease the strength of molarity of the degradation medium or exposure time)
If degradation medium do not degrade the product after best possible actions then observation and summary of the experiment should be documented accordingly in record sheet.
The sample should be neutralized after stressing with Acid /Base at appropriate stage of the sample preparations.
Inject the Blank /Placebo, standard and Test solution (with and without degradations) in to the system and record the peak purity of main peak and impurities in the record sheet.
For stability indicating method, Demonstrate of specificity shall include API stored under relevant stress conditions (e.g. : Light, Heat, Humidity, Acid/Base hydrolysis, Oxidation and Metal) .
In case where degradation pathway have been established, degradation product have been identified and authentic substances are available there is no need to perform before degradation.
Note : The data obtained from force degradation studies are used to establish the shelf-life or expiration date of the drug substance or product and can be used to develop appropriate storage and handling recommendations.
Why Force Degradation Study (FDS) is Required in Pharmaceuticals ?
Force degradation study (FDS) is required in the pharmaceutical industry for several reasons some of the reasons mentioned as below :
- To Assess Product stability
- To Comply with Regulatory requirements
- To Optimize Formulation and Manufacturing processes
- To Establish storage and handling recommendations
- To Investigate product failures
- To Support product development
- To Ensure Batch-to-Batch consistency
