Stability Testing of pharmaceutical products and storage follow a complicated set of procedures involving substantial time, cost and scientific expertise so as to build in quality, efficacy and safety in drug formulations. Stability testing or GMP stability testing is crucial at each step during medication or product development to find out the shelf life and storage requirements in conformance with specified standards.Stability Testing or studies is a number of the most important step during the drug development process since it is required to guarantee the identity, potency and purity of ingredients, in addition to those of the formulated pharmaceutical products or Active Pharmaceutical Ingredients API. Assessment of the formulas or products contrary to changing environmental conditions such temperature, light, moisture, etc. provide pertinent, real-time insights about their software and how they may differ because of changes in storage variables.
For a Pharmaceutical or chemical company, selecting an experienced equilibrium partner who owns the perfect infrastructure such as stability walk-in chambers, photostability room, etc. And the analytical tools for Stability Testing can determine the product failure or success.Precise Analytics Lab. is well equipped with stability walk-in chambers which could be placed at different temperatures and humidity with supported observation systems. We also carry a photo stability room to perform photo stability testing. Our technologically-enhanced stability testing labs and seasoned analysts and scientists offer GMP stability testing for pharmaceutical companies.Our stability testing processes Serve to increase product and drug development by crucial identification of equilibrium that is crucial for product validation. Stability testing involves determining degradation variables and time required for degradation. Routine assays for a variety of parameters like temperature, moisture content, residue existence, microbial existence, etc. will also be conducted.
Throughout the period of stability Testing, we occasionally test for identification, physical appearance, disintegration, dissolution, loss on drying, related materials, assay, residual solvents, microbial testing etc., to ascertain the accurate stability of merchandise. Our seasoned staff and high-technology infrastructure complement one another to offer stability studies which are dependable in real-time conditions thought the product lifecycle.With the suitable storage, shelf life, and supply methods ascertained, the standard of APIs and drug products is guarded. Alcamo has extensive experience setting stability programs across all stages of the drug product lifecycle from early stage to annual business stability requirements. Each protocol describes the packing, storage requirements and the Tests which will be performed, together with stability test dates, test durations, etc. Stability tests are conducted with the same container closure system and packaging materials which are meant for the final product.