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FAQ: Protheragen's Comprehensive Drug Analysis Solutions for Pharmaceutical Development
TL;DR
Protheragen's integrated drug analysis services give pharmaceutical companies a competitive edge by streamlining development and strengthening quality assurance for faster regulatory approval.
Protheragen's drug analysis employs stability, impurity, and chemical-physical tests using LC-MS, GC-MS, and NMR instruments to systematically ensure product safety and regulatory compliance.
Protheragen's rigorous testing services help ensure pharmaceutical products are safe and effective, contributing to better patient outcomes and enhanced public health worldwide.
Protheragen uses forced degradation studies with extreme stressors like heat and light to predict drug shelf life and identify degradation pathways.
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Protheragen provides three integrated services: stability testing (including accelerated and real-time studies), impurity testing (targeting organic, inorganic, heavy metal, elemental, residual solvent, and genotoxic impurities), and chemical-physical testing (covering parameters like relative density, melting point, optical rotation, viscosity, particle size, dissolution, and oxygen/water vapor transmission rates).
These solutions ensure product safety, efficacy, and regulatory compliance while streamlining drug development and strengthening quality assurance throughout the pharmaceutical product lifecycle, from early development to regulatory submission and commercialization.
Protheragen conducts accelerated stability studies using elevated temperature and humidity to predict degradation pathways and shelf life, and real-time stability studies over the recommended product lifespan to monitor long-term performance. They also perform forced degradation studies by exposing drug substances to extreme stressors like heat, light, humidity, acid/base hydrolysis, and oxidation.
Chemical-physical tests cover relative density, melting point, optical rotation, viscosity, particle size and morphology, dissolution, disintegration, and oxygen/water vapor transmission rates (OTR & WVTR) to ensure optimal drug formulation, compatibility, and bioavailability.
The impurity testing service targets organic, inorganic, heavy metal, elemental, residual solvent, and genotoxic impurities that may result from manufacturing byproducts, environmental exposure, and degradation processes.
Protheragen uses advanced analytical instruments including LC-MS, GC-MS, NMR, HPLC, and dynamic light scattering (DLS) to quantify degradation levels, validate stability-indicating methods, and deliver data-driven recommendations.
Protheragen adheres to international guidelines including ICH standards, ensuring their studies meet the highest quality and regulatory requirements for pharmaceutical analysis.
Protheragen maintains a transparent service process from initial consultation and project planning to analysis, reporting, and follow-up support, ensuring clients remain fully engaged and informed at every stage while delivering accurate, reliable results within agreed timelines.
You can learn more about Protheragen's drug analysis services at their drug analysis services page and their forced degradation studies page.
Protheragen is an ISO9001-certified supplier of pre-clinical contract research service and analytical service with a team of experienced scientists who bring deep expertise in pharmaceutical analysis.
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