Pharmaceutical stability testing is essential to the development and production process, because it helps determine parameters like shelf life, ideal storage conditions, and retesting intervals for pharmaceutical items.
Protheragen-ING ensures the safety, effectiveness, and quality of your medications by providing a wide range of analytical stability testing services to evaluate shelf life, degradation pathways, and storage conditions for pharmaceuticals.
Types of Stability Studies
Accelerated Stability Studies - Studies on accelerated stability are intended to evaluate the stability of pharmaceuticals under extreme storage circumstances. We are able to predict degradation pathways and determine its shelf life by subjecting it to high temperatures, high humidity, and other stresses.
Real-Time Stability Studies - This form of stability testing is performed on a drug for the same period of time as the recommended shelf life. Through regular testing conducted at pre-arranged intervals, we may evaluate the product's stability, detect any changes, and ascertain whether it continues to operate within reasonable bounds.
Forced Degradation Studies - Studies on forced degradation are carried out to mimic harsh environments and pinpoint possible drug degradation routes. We can understand the product's intrinsic stability features and create mitigation plans by exposing it to a range of stressors, including heat, light, humidity, and oxidation.
Our Stability Testing Services
Our stability testing services include the long-term accelerated shelf-life test and the light stability test, which simulate a variety of environmental conditions to provide valuable data on product degradation kinetics, impurity formation and packaging compatibility.
Protheragen-ING deliberately accelerates the aging process of its products by exposing them to high temperatures and humidity conditions that exceed typical storage conditions. By analyzing the degradation rates at different temperatures and the relationship between these temperatures, we can deduce the shelf-life of the product when stored under standard conditions.
A crucial factor in the creation of pharmaceuticals and other products is light stability. Pharmaceutical items can have substantial quality and efficacy losses due to light-induced deterioration. Maintaining well-light stability is crucial to guaranteeing the efficacy, safety, and quality of products.
Protheragen-ING is able to determine a product's sensitivity to photodegradation and provide suggestions for suitable packaging and storage.
Evaluation Criteria
Evaluation criteria during stability studies may include the following tests:
- Physical changes - Color changes, moisture content levels, pH changes, viscosity changes, presence of crystalline substances, and differences in dissolution and disintegration characteristics from the date of packaging.
- Chemical changes - Presence of residual solvents, related substances and any degradation by-products.
- Microbiological changes - The presence of pathogenic microorganisms, and the effectiveness of added microbiological preservatives.
Stability Indicator Method Development
Protheragen-ING uses cutting-edge analytical techniques including mass spectrometry (MS), gas chromatography (GC), and high-performance liquid chromatography (HPLC) to create reliable procedures that can separate and measure APIs and their degradation products.
Our skilled scientists make sure that the approach is precise, sensitive, accurate, and specific in order to evaluate the stability of your medication product.
Contact us today to discuss your pharmaceutical stability testing requirements and learn how we can help you ensure the quality and safety of your pharmaceutical products. We will respond within 2-4 working days.
