Protheragen, an ISO9001-certified provider of pre-clinical contract research and analytical services, announced today its comprehensive drug analysis solutions that integrate stability testing, impurity testing, and chemical-physical testing to support the pharmaceutical product lifecycle. The company's offerings are designed to address critical needs from early development through regulatory submission and commercialization, ensuring product safety, efficacy, and compliance.
The drug analysis services encompass rigorous chemical-physical and targeted impurity evaluations. Chemical-physical tests cover parameters such as relative density, melting point, optical rotation, viscosity, particle size and morphology, dissolution, disintegration, and oxygen/water vapor transmission rates (OTR & WVTR). These analyses ensure optimal drug formulation, compatibility, and bioavailability. The impurity testing service targets a broad range of contaminants, including organic, inorganic, heavy metal, elemental, residual solvent, and genotoxic impurities, mitigating risks from manufacturing byproducts, environmental exposure, and degradation processes.
Stability testing is a cornerstone of Protheragen's portfolio, including accelerated stability studies that use elevated temperature and humidity to predict degradation pathways and shelf life, as well as real-time stability studies conducted over the recommended product lifespan. Forced degradation studies are central to these efforts, exposing drug substances and formulations to extreme stressors such as heat, light, humidity, acid/base hydrolysis, and oxidation. Using advanced analytical instruments like LC-MS, GC-MS, NMR, HPLC, and dynamic light scattering (DLS), Protheragen quantifies degradation levels, validates stability-indicating methods, and delivers data-driven recommendations for formulation optimization.
Protheragen's services are distinguished by a commitment to technical excellence, regulatory compliance, and client-centricity. The company's team adheres to international guidelines, including ICH standards, ensuring studies meet the highest quality and regulatory requirements. With customized study designs and transparent communication from initial consultation to reporting, Protheragen enables clients to make informed decisions promptly.
Pharmaceutical organizations seeking to enhance development workflows or meet regulatory obligations can contact Protheragen for their project requirements. The company promises to respond within 2-4 working days, offering tailored solutions to support drug development goals.
