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Degradation studies are required to understand how a molecule responds to stress, but outsourcing the study shouldn't place added pressure on you. As a true outsourcing partner, ABC Laboratories has the knowledge to help you determine what type of degradation study suits your needs. Whether you need a forced degradation study, a degradation pathway study, or both, you can rest assured that we'll deliver the answers and defensible data you need to advance your CMC development program.
ABC's large team of expert analytical and synthetic chemists have identified and quantified hundreds of degradants and impurities, and they are ready to assist with identifying and validating complex pathway questions. This combination of the industry's most talented chemists and advanced instrumentation can develop effective stability methods, identify unknowns and determine the pathways of your molecule.
Forced degradation
A forced degradation study subjects your molecule to more strenuous chemical & physical stress than a typical stability study, but less stress than a degradation pathways study. Once your molecule is degraded, our team of method development experts can use your sample to help in developing or demonstrating a stability-indicating analytical method.
Degradation pathways
A degradation pathways study requires capable chemists who can interpret the behavior of your molecule through its entire devolution. At ABC Laboratories, our team of chemists will intentionally degrade your molecule by 40 to 70 percent. Then, once the molecule is degraded, our chemists will determine the structure of the resulting molecule & the pathway of the molecule's devolution.
Whether you need reliable data for regulatory, formulation development, manufacturing or packaging purposes, you can place your degradation study with ABC Laboratories & stay calm, cool & collected. Because when the stress is on, ABC Laboratories performs.
Click to see a list of ABC's Specialized Analytical Instrumentation
ABC gives you the reliable results you need to make critical decisions about API manufacturing and packaging. So from start to finish, your molecule will experience stress, but you don't have to. |
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