Determining the steadiness of pharmaceutical products is important in order to ensure safety of the patient & desired clinical results. The presence of harmful degradation products & loss of efficiency may lead to dangerous consequences. Therefore, stability testing takes place routinely on pharmaceutical products at every stage of development.
Testing is necessary to assure that drug product retains the required efficiency & purity after it’s transported & stored. Different components of pharmaceutical product, which includes active pharmaceutical ingredient may undergo physical alterations due to vibration, humidity, impact, degradation, and microbiological alterations. These changes may decrease its effectiveness or even lead to creation of a harmful degradation product.
Importance of Stability Testing
Detailed examination takes place to offer confidence that pharmaceutical products retain post-production levels of quality until they are delivered to the customers. Stability testing outcomes are used to offer an indication on product label, wherein it is confirmed that the medication will be effective & safe.
Testing is now controlled by stringent rules & stability testing data are needed for a novel drug or creation to get administrative sanction. All the components & products of imposed degradations should be parted & separately attributed with the help of confirmed methods.
Therefore, stability testing is a complicated method as the impact of several factors that may affect stability should be evaluated. Additionally, drug companies are becoming very complicated, creating more issues to accomplish dependable separation & recognition of all components. It has boosted the need for sensitive & inexpensive analytical techniques.
Stability-Indicating Test Development
Stability showing examination must be particularly designed for every single drug product so that active ingredients content & degradation products can be correctly determined. Given that no single parameter that can outline complicated pharmaceutical products, producer is asked to suggest a stability-indicating method & show that it is sufficient to discover alterations in identity, purity & potency of their medicine.
Pharmalytik’s Kim HuynhBa at Pittcon 2019, will be explaining the significance of correctness & exactness in stress testing methods. She will also explain important things to take into account the creation & confirmation of stability-indicating techniques in her presentation.
Furthermore, MWD Consulting’s Michael Dong will explain methods to speed up method development of UHPLC, which includes a three-pronged technique template approach in the same event.