Stability Studies

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  • Published date: April 1, 2019
    • Shirley, New York, United States

Stability studies have critical effect on the pharmaceutical development since it provides the essential data that illustrates how the environmental factors such as temperature, humidity and photostability influence the quality of drug products. When we have a comprehensive analysis of these pivotal data, the retest period for a drug substance or a shelf life and recommended storage conditions for a product can be efficiently established.

We have comprehensive capabilities to provide a suit of stability testing services for drug substances and a variety of dosage forms such as the solid oral dose, inhaled and nasal, parenteral and topical or creams. By a systematic evaluation of your API or drug product, our experts will give you a comprehensive report to assist you assign a shelf life (re-test period). Additionally, your stability testing services of your samples will be conducted according to the specific procedures and timetables.

BOC Sciences also offers forced degradation studies under extreme storage conditions to determine the product breakdown and degradation pathways. Through the method of accelerating the degradation rate of products, we can obtain the data which is particularly useful in early drug development to facilitate formulation design and determines the storage conditions.

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