Impact Analytical is a leading supplier of stability testing services and accelerated stability studies. Understanding the stability of a good or substance against the effects of temperature, time and/or humidity is an important part of product development. While this is essential to the pharmaceutical industry, it is of equal value to the consumer product, food, and beverage sectors. Impact Analytical has the testing facilities to safely run the desirable stability or shelf-life study, in addition to the corresponding analytical testing to assess the impacts of the storage requirements. Examples of these effects include.
- Material degradation
- Pharmaceutical API stability
- Consumer product active ingredient equilibrium
- Shelf life evaluation
- Packaging integrity evaluation
- Raw material and chemical equilibrium
We perform Stability studies and accelerated Stability Testing on many unique products and materials, and under diverse storage conditions. Whether you require long Term stability storage conditions or accelerated storage requirements, Impact Analytical has expertise in executing stability testing for cosmetics, pharmaceuticals, medical devices, and specialty chemicals under cGMP and GLP requirements and guidelines. We can create methods for Testing stability samples, or follow prescribed testing procedures like US Pharmacopeia and EPA OPPTS requirements.With regard to new drug Programs, admissions for acceptance by regulatory authorities are expected to include data from stability studies conducted on both the drug substance and the drug product.
During drug development, this evaluation is done with the support of an assortment of well-designed equilibrium studies in the various development stages. During early growth, stability studies are conducted on specialized batches in addition to on clinical samples. These include, by way of instance, rapid and stress studies of the drug substance and product to support installation of formulation, selection of primary packaging, and manufacturing procedure. In later phases, biking and transport studies in addition to long-term and accelerated studies with enrolment batches are realized. All information are compiled to create the expiry date of the medication and, finally, to acquire the market authorization.