Stability Testing of GPCRs
Creative Biolabs provides comprehensive stability testing of new drug substances targeting GPCRs. We offer expertise and advanced technology to help our customers cope with increasing and unexpected challenges of time, quality and cost.
Introduction of Stability Testing
Stability testing in drug development aim to provide evidence on how the quality of a drug substance or product and its packaging varies with time under the influence of various environmental factors, including temperature, humidity, and light. Any microbiological, physical, and chemical changes that may affect the efficiency and integrity of the final product need to be evaluated to ensure safety and effectiveness. Stability testing also establish the re-test period for drug substances, as well as the shelf life and recommended storage conditions for pharmaceutical products.
Stability testing is a complex set of procedures. The most suitable approach to gathering data is to conduct real-time stability testing. It is usually necessary to study under at least two different storage conditions: long-term and accelerated conditions. For long-term studies, the frequency of test points should be sufficient to establish the stability profile of the drug substance. At the accelerated storage conditions, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), are recommended. Prior to the approval of new products, it has become a legal requirement to provide data the regulatory agencies with certain types of stability test data.
Figure 1. Various steps involve in the stability study. (Maheshwari R, et al., 2018)
Our Featured Services
We are proud to offer powerful and reliable services for stability testing of your drug candidates. Browse our featured services below or use our online inquiry form to get more information.
Real Time (Long-Term) Stability Testing
We provide real time (long-term) stability testing services conducted under controlled temperature and humidity approximating conditions of long-term storage following the guidelines.
Intermediate Stability Testing
We provide intermediate stability testing services conducted under conditions that are between long-term and accelerated storage conditions when a failure in encountered during accelerate stability testing.
We provide accelerated stability testing services conducted under exaggerated conditions in an attempt to accelerate the rate of physical change and/or chemical degradation.
We provide forced degradation studies under exposure to heat, light or chemical agents to predict the stability of pharmaceutical products that affects purity, effectiveness, and safety.
We provide photostability testing services conducted under exposure to whole or ultraviolet light to describe the photodegradation approaches and the biological consequences of drugs.
Creative Biolabs provides customized services and tailored one-stop solutions in a high-quality, timely and cost-effective manner. Our experienced scientific team will work closely with our customers to help them achieve their goals.
If you are interested in our services or have any specific needs, please feel free to contact us for more details.
References
- Maheshwari R, et al. Stability and Degradation Studies for Drug and Drug Product. Dosage Form Design Considerations. Academic Press, 2018: 225-257.
- Bajaj S & Singla D, Sakhuja N. Stability testing of pharmaceutical products. J App Pharm Sci, 2012, 2(3): 129-138.