Our Services – Pharmaceuticals & Veterinary Medicine
Forced degradation services
Forced Degradation Services
Ensuring Drug Stability and Safety with Advanced Forced Degradation Testing
Forced degradation plays an important role in stability testing during drug development. It involves subjecting a pharmaceutical product or veterinary medicine to extreme conditions, such as high temperatures, humidity, and oxidation, to accelerate its degradation process. This testing helps identify potential degradation products, evaluate the drug’s stability and gain insight into how it will behave under different environmental conditions. Forced degradation is a key component of the analytical method development as detecting the degradant from your active will demonstrate achievement of a stability-indicating method.
CEMAS offers guidance in designing comprehensive forced degradation studies, leveraging detailed feasibility analyses to identify Critical Quality Attributes (CQAs) and generate comparability data. Our approach ensures that degradation pathways are thoroughly explored, providing valuable insights that support the development of robust, stable formulations. Whether you are evaluating new drug candidates or comparing biosimilars to reference products, our tailored solutions deliver the data necessary to meet regulatory requirements and advance your product through the development pipeline with confidence.
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Forced Degradation: What can CEMAS do for you?
Our forced degradation services provide a thorough evaluation of your drug’s stability profile and overall safety. These include:
- Stress Testing: Simulating extreme conditions such as elevated temperatures, humidity, and light to determine how your drug degrades over time.
- Degradation Pathway Analysis: Identifying and characterising degradation products to assess potential impacts on drug efficacy and safety.
- Formulation Development Support: Using forced degradation data to optimise formulations and improve drug stability.
Specific examples of our Forced Degradation Services:
- Thermal Stress Testing: Evaluates product stability under elevated temperatures.
- Acid / Base Stress Testing: Assesses the impact of Acidic / Basic conditions on product integrity.
- Oxidative Stress Testing: Assesses the impact of oxidative conditions on product integrity.
- Hydrolytic Stress Testing: Determines the effects of moisture and pH variations on product stability.
- Light Exposure Testing: Simulates exposure to light to evaluate the photostability of your product.
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
