The scientific rigor behind the quality standards trusted by manufacturers and regulators around the globe – now available through USP’s R&D Analytical Solutions
New manufacturing technologies and increasingly complex drug formulations pose challenges for manufacturers and pharmaceutical companies to bring products to market.
USP’s analytical method development and qualification services support in-lab analytical and process development for pharmaceutical R&D. We provide flexible, tailored solutions to help develop and validate* analytical methods, procedures for characterizing drugs and related materials including analytical standards, and methods and processes to identify and control potential impurities.
Method development and validation* and
material characterization services include:
• Assays, including stability indicating tests
• Process impurities, residual solvents, potential, mutagenic impurities, and unknowns
• Cleaning validation
• Purity analysis
• Structural characterization
• Material isolation and identification
* Non-GMP, Non-GLP
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. This includes actively collaborating with academic research centers, industry, and regulators to help advance pharmaceutical continuous manufacturing standardization efforts. USP's advanced manufacturing solutions facilitate adoption of new technologies to help accelerate the safe and efficient production of quality medicines when and where they are needed.
Email us at Advancing_Manufacturing@USP.org to see how USP can help address your R&D analytical and process development challenges.