Defining the equilibrium of a pharmaceutical product is vital to ensuring patient safety and the desired clinical outcomes. Both the existence of toxic degradation products and the reduction of efficacy can have deadly consequences. Stability testing is thus routinely performed on pharmaceutical products at every stage of development.Such testing is essential to ensure that the drug product Maintains the desired efficacy and purity after storage and transportation. Different constituents of the pharmaceutical solution, including the active pharmaceutical ingredient, have the capacity to experience physical changes as the result of impact, vibration, abrasion, changes humidity and temperature, microbiological changes or degradation reactions. Such changes may in turn reduce its effectiveness, or contribute to the creation of toxic degradation products.
Rigorous testing is conducted to provide assurance that Pharmaceutical products maintain post-production excellent levels until the time they reach customers. The results of stability testing are utilised to give an indicator on the product label of the time up to which it is ensured that the medicine will be safe and effective.Such testing is now governed by strict regulations, and Stability testing information are needed for a new drug or formula to get regulatory approval. All products and ingredients of enforced degradations have to be separated and individually characterised using validated methodologies.Stability testing is thus a complex process as the effects of a Number of factors that may influence stability has to be assessed. Additionally, drug entities are getting increasingly more complicated, posing more obstacles to attaining reliable separation and identification of constituents. This has driven the requirement for increasingly sensitive and cost-effective analytical methods.
Stability-Indicating Test Development
A Stability Testing has to be specifically tailored for Each drug product so the content of active ingredients and degradation products can be accurately quantified. Since there isn’t any single assay or parameter that could characterize complex pharmaceutical products, the producer is needed to suggest a stability-indicating methodology and demonstrate it is sufficient to detect changes in the identity, purity and potency of the merchandise.At Pittcon 2019, Kim Huynh of Paralytic will be talking the importance of accuracy and precision in pressure testing methodologies and the key elements to take into account in the development and validation of stability-indicating methods in her presentation entitled Key aspects to Develop Stability-Indicating techniques for Pharmaceutical Products.