The United States Pharmacopeial Convention, Inc.
US Pharmacopeia (USP) is an independent scientific organization dedicated to developing quality standards for medicines, dietary supplements, and food ingredients. With a history spanning over 200 years, USP collaborates with global experts to create enforceable standards that ensure the safety, quality, and efficacy of health products worldwide. USP's standards include documentary and reference standards, and the organization actively supports innovations in manufacturing, quality control, and supply chain resilience to improve global health.
Industries
Nr. of Employees
large (251-1000)
The United States Pharmacopeial Convention, Inc.
Products
Official reference standards (physical reference materials)
Authenticated, highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements and food ingredients used as benchmarks for testing.
Medicine Supply Map (graph-based predictive model)
A graph-based predictive data model that applies machine learning and advanced analytics to generate insights about upstream medicine supply-chain disruptions.
Food Chemicals Codex (FCC) Online and FCC analytical materials
Integrated online platform combining the Food Chemicals Codex content and forum plus associated analytical reference materials for food-ingredient identity and purity testing.
Dietary Supplements Compendium (DSC) and Herbal Medicines Compendium (HMC)
Annual compendia providing documentary standards, monographs, safety reviews and quality-control guidance specific to dietary supplements and herbal medicines.
DEG Tool Kit (contaminant detection resources)
A toolkit for measuring and controlling levels of diethylene glycol and ethylene glycol contamination intended for manufacturers and regulators.
Nitrosamines Exchange (collaborative information platform)
Open-access platform for manufacturers, scientists and other stakeholders to share real-time updates, learnings and mitigation approaches related to nitrosamine impurities.
Official reference standards (physical reference materials)
Authenticated, highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements and food ingredients used as benchmarks for testing.
Medicine Supply Map (graph-based predictive model)
A graph-based predictive data model that applies machine learning and advanced analytics to generate insights about upstream medicine supply-chain disruptions.
Food Chemicals Codex (FCC) Online and FCC analytical materials
Integrated online platform combining the Food Chemicals Codex content and forum plus associated analytical reference materials for food-ingredient identity and purity testing.
Dietary Supplements Compendium (DSC) and Herbal Medicines Compendium (HMC)
Annual compendia providing documentary standards, monographs, safety reviews and quality-control guidance specific to dietary supplements and herbal medicines.
DEG Tool Kit (contaminant detection resources)
A toolkit for measuring and controlling levels of diethylene glycol and ethylene glycol contamination intended for manufacturers and regulators.
Nitrosamines Exchange (collaborative information platform)
Open-access platform for manufacturers, scientists and other stakeholders to share real-time updates, learnings and mitigation approaches related to nitrosamine impurities.
Services
Verification services for dietary supplements
Multi-step verification program to assess and verify ingredient and finished-product quality for dietary supplements and dietary ingredients.
Advanced manufacturing consulting and capability-building
Advisory and implementation support for adopting advanced manufacturing technologies and analytical quality practices to strengthen local production capacity.
Supply-chain analytics and early-warning services
Analytics and reporting services that use predictive models to identify supply-chain vulnerabilities and forecast potential disruptions to drug ingredients and finished products.
Standards development and public consultation services
Management of standards development processes, public comment periods, and volunteer expert engagement to establish or revise compendial standards.
Laboratory reference standards testing and analytical services
Laboratory testing, synthesis support and analytical development to produce and verify reference materials and to support compendial testing needs.
Verification services for dietary supplements
Multi-step verification program to assess and verify ingredient and finished-product quality for dietary supplements and dietary ingredients.
Advanced manufacturing consulting and capability-building
Advisory and implementation support for adopting advanced manufacturing technologies and analytical quality practices to strengthen local production capacity.
Supply-chain analytics and early-warning services
Analytics and reporting services that use predictive models to identify supply-chain vulnerabilities and forecast potential disruptions to drug ingredients and finished products.
Standards development and public consultation services
Management of standards development processes, public comment periods, and volunteer expert engagement to establish or revise compendial standards.
Laboratory reference standards testing and analytical services
Laboratory testing, synthesis support and analytical development to produce and verify reference materials and to support compendial testing needs.
Expertise Areas
- Compendial standards development
- Reference material production and characterization
- Analytical method development for complex matrices
- Supply-chain analytics and drug shortage mitigation
Key Technologies
- Machine learning for supply-chain analytics
- Graph-based predictive modeling
- Continuous flow and advanced manufacturing methods
- Advanced analytical quality solutions