API/Pharmaceuticals Stability Testing
During the production, storage, and transportation of APIs or pharmaceutical products, environmental factors such as temperature, light, and humidity may affect the physical, chemical, and biological properties of these products, resulting in changes in their safety and efficacy. The purpose of stability testing is to determine whether the API or drug can maintain its safety and effectiveness under specific storage conditions and within a specified period of time, which is helpful for the determination of product shelf life and storage conditions. Creative BioMart Microbe provides comprehensive stability research services to accelerate the research and development of APIs or pharmaceutical products. Experienced teams and first-class testing platforms can meet your testing needs.
Stability Testing
Stability testing is an important part of the development process of active pharmaceutical ingredients and pharmaceutical products. Stability testing needs to be carried out at certain time intervals under specific storage conditions. Stability testing of APIs or pharmaceutical products includes long-term stability studies, mid-term stability studies and accelerated stability studies. Long-term stability testing is usually performed under expected storage conditions and the study period lasts 12 months or more. Long-term stability testing is critical to determining product shelf life. Accelerated stability studies also contribute to the determination of shelf life and drug stability, which are generally performed under exaggerated stress conditions.
Stability Testing Services for APIs or Drug Products in Creative BioMart Microbe
- Long-term stability Testing
- Accelerated Stability Testing
- Cyclic Temperature Stress Testing
- Formulation Evaluation Stability Testing
- Forced degradation studies
- In-use stability studies
Test Conditions
- 2-8°C
- 25°C at 60% RH
- 30°C at 65% RH
- 40°C at 75% RH
- -20°C
- -80°C
The test conditions are not limited to the above, please feel free to contact us for other test conditions we can provide.
Test Parameters
- Physical properties: Colour and clarity, appearence, melting point, water content, pH value, viscosity, dissolution and disintegration properties
- Chemical properties: the presence of degradation by-products, residual solvents and related substances
- Microbiological properties: the presence of pathogenic microorganisms and the effectiveness of added microbial preservatives
Due to the different parameters of the products, we can provide the test of other related parameters in addition to the above parameters according to the customer's requirements.
Why Choose Creative BioMart Microbe?
- Multiple stability testing services to help customers conduct comprehensive stability analysis of the product.
- The experienced team and strict and standardized testing procedures ensure the accuracy and reliability of test results
- Personalized research solutions and affordable prices.
- Realize real-time technical communication and tracking services.
Workflow of API/Pharmaceuticals Stability Testing in Creative BioMart Microbe
Creative BioMart Microbe also offers services to design customized stability studies for your product. If you are looking for stability study services for APIs or pharmaceuticals, please feel free to contact us for more information.
