Stability Studies Training

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  • Forced Degradation Stability
  • Long Term Storage Stability

Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Stability studies provide the supporting data that companies use to establish product storage requirements and expiration dating.

Stability testing studies, how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. This study helps to determine the shelf-life of that product. Storage condition recommendation:Different products require different storage conditions.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug.how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity and light.” To support a stability study, analytical methods using HPLC, LC/MS and GC are used to test for degradation products apart from tests to determine the sterility of the substance and whether the container or packaging of the final commercial product is compromised.

Pharmaceutical companies arrive at optimum storage conditions and the expiration date of a drug substance or drug product which can be seen commonly on drug labels after collecting stability data over months to years. This data includes the effects of environmental conditions which can significantly alter the physicochemical characteristics, biological activity and other attributes of the drug substance or product. Stability studies are performed for medical devices and raw materials as well.

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