Forced Degradation Study & Impurity Analysis

Forced degradation, also known as stress testing, refers to the artificial method of forcing drug degradation. It is an effective tool for predicting the stability of active pharmaceutical ingredients (API) or formulation products. It helps to understand the impurities generated during the storage of drugs under various environmental conditions.

Protheragen Impurity specializes in providing high-purity drug impurity reference standards and comprehensive impurity research services. With a strong team of analytical chemistry experts and cutting-edge instruments, we can offer a comprehensive, compliant, and efficient service for forced degradation studies and impurity analysis to help you identify and characterize degradation products generated during drug development and storage processes, reducing R&D risks, accelerating product launch, and ensuring patient safety. If you have any needs, please contact us immediately to get a customized solution and quote!

Our Services

We offer comprehensive forced degradation studies aligned with international standards, covering major degradation pathways. Utilizing advanced analytical technologies, we provide precise identification and quantitative analysis of degradation impurities.

Hydrolytic Degradation

Hydrolysis is a common degradation process where the reaction of a drug with water is observed at different pH levels. We use HPLC/UHPLC to monitor the decrease in the main drug content and the growth of hydrolytic impurities, and use LC-MS to determine the molecular weight and speculate the structure of the generated hydrolytic impurities.

Oxidative Degradation

Oxidative degradation evaluates the sensitivity of drug molecules to oxidizing agents, especially molecules rich in phenolic hydroxyl groups, thioethers, heterocycles, or carbon-carbon double bonds. We simulate potential oxidative processes with various oxidizing agents and models, and precisely identify the structure of oxidative degradation products via LC-MS and other instruments, clarifying the sites and sequence of oxidation.

Photolytic Degradation

Light stability is an important basis for drug labeling and packaging selection. Photostability testing of any drug is to determine the impact of light on the drug during storage. We conduct comprehensive analyses of samples before and after exposure to light, using HPLC and LC-MS to identify photodegradation impurities, evaluate the photosensitivity of the drug, and provide crucial recommendations for product packaging, storage, and transportation conditions.

Thermal Degradation

Temperature has a greater impact on the stability of drug substances compared to other conditions. Thermal degradation studies are conducted to evaluate the stability of drug molecules at high temperatures, providing a basis for thermal processing (such as sterilization, drying) and setting storage conditions. We systematically analyze samples after thermal stress, separating and identifying thermal degradation impurities.

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