Eurofins Sinensis can help you with your Forced Degradation Study. Forced degradation studies (stress testing) play a central role during formulation development, manufacturability assessment and analytical method development.
Eurofins Sinensis is able to develop stability indicating methods for monitoring results during stability studies in order to guarantee safety, efficacy and quality. A stability indicating method is a method that accurately and precisely measures a drug substance or drug product well separated from process impurities, excipients and degradation products. Stress tests generate representative samples to assess drug substance and drug product stability, provide information about possible degradation pathways and demonstrate the stability indicating power of the analytical procedures applied.
For a Forced Degradation Study Eurofins Sinensis standard includes alkaline and acid hydrolysis, photolysis, oxidation, humidity and temperature stress. Other conditions can be added upon request or after evaluation of the first results. All information is documented in protocols and reports to ensure a Stability Indicating Method which can be validated.
Forced degradation studies are carried out for the following reasons:
- To develop and validate a stability indicating method
- To determine degradation pathways of drug substances and drug products (e.g., during development phase)
- To identify impurities related to drug substances or excipients
- To understand the drug molecule chemistry
- To generate more stable formulations
- To generate a degradation profile that mimics what would be observed in a formal stability study under ICH conditions
- To solve stability-related problems (e.g., mass balance)
Examples of typical stress conditions are:
- elevated temperature and or humidity conditions
- photostability testing according to ICH
- extreme pH conditions
- oxidative conditions
If you require advice or more information on standard or tailor made Forced Degradation studies, please
contact us to discuss your specific needs.
- Eurofins Sinensis helps to ensure your success and the success of your company through careful analysis and high-quality services.
- Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.
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