Protheragen Enhances Drug Development with Advanced Analysis Solutions

Protheragen, an ISO9001-certified supplier of pre-clinical contract research and analytical services, is reinforcing its pivotal role in the pharmaceutical industry by offering a comprehensive suite of specialized drug analysis solutions. The company's integrated offerings are designed to support the entire pharmaceutical product lifecycle, from early development through regulatory submission to commercialization. A company spokesperson emphasized that pharmaceutical companies depend on rigorous testing to ensure product safety, efficacy, and compliance, and Protheragen's solutions are tailored to meet these critical demands. By combining stability studies with impurity test capabilities, the company provides end-to-end support that streamlines drug development and strengthens quality assurance processes.

At the core of Protheragen's portfolio are its detailed drug analysis services, which include rigorous chemical-physical and targeted impurity evaluations. The chemical-physical tests cover essential parameters like relative density, melting point, optical rotation, viscosity, particle size and morphology, dissolution, disintegration, and oxygen/water vapor transmission rates, ensuring optimal drug formulation, compatibility, and bioavailability. Complementing this, the impurity test service targets a broad spectrum of contaminants—including organic, inorganic, heavy metal, elemental, residual solvent, and genotoxic impurities—to mitigate risks from manufacturing byproducts, environmental exposure, and degradation, thereby upholding product purity and safety. The stability test services are a cornerstone, featuring 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 product's recommended lifespan to monitor long-term performance.

Central to Protheragen's stability testing efforts are forced degradation studies, a critical component for drug development and regulatory compliance. These studies expose drug substances and formulations to extreme stressors such as heat (dry and wet), light, humidity, acid/base hydrolysis, and oxidation to identify intrinsic stability characteristics and degradation pathways. Leveraging advanced analytical instruments like LC-MS, GC-MS, NMR, HPLC, and dynamic light scattering, the team quantifies degradation levels, validates stability-indicating methods, and provides data-driven recommendations for formulation optimization to enhance product shelf life and stability. Protheragen's services are distinguished by a commitment to technical excellence, regulatory compliance, and client-centricity, with experienced scientists adhering to international guidelines like ICH standards. The company invites pharmaceutical organizations to contact Protheragen to discuss project requirements, promising tailored solutions and a response within 2-4 working days to support clients in achieving their development goals.