About Us - impurity

Your Trusted Partner for High-Purity Drug Impurities!

Impurities in drugs directly impact the safety, efficacy, and stability of the drug. Impurity research is a critical component of drug development and quality control, not only pivotal for the successful approval of drug marketing applications but also fundamental to safeguarding patient medication safety. Protheragen Impurity is dedicated to providing a range of drug impurity reference standards with the highest purity and most complete data, along with related services, for global new drug development, generic drug development, quality control, and regulatory submissions.

10+

Years of Industry Experience

40,000+

High-Quality Products

5,380

Square Feet Warehouse in New York

Our Capability

Our mission is to assist pharmaceutical companies in accurately identifying, quantifying, and controlling impurities in drugs, reducing drug development risks, accelerating the drug approval process, and ultimately providing safer and more effective treatments for patients worldwide.

Comprehensive Impurity Library

Our product portfolio encompasses nearly all categories of impurities, including process-related impurities, degradation impurities, genotoxic impurities (GTIs), elemental impurities, residual solvents, and chiral impurities.

Advanced Analytical Technologies

Equipped with state-of-the-art analytical instruments such as HPLC, GC, and MS, we can accurately identify and quantify trace and even ultra-trace levels of impurities in pharmaceuticals.

Extensive Preparation Experience

With extensive experience in impurity preparation, our team excels in the rapid enrichment, purification, and synthesis of high-purity drug impurities to support the control of impurities.

End-to-End Services

The structure and properties of impurities are critical for drug risk management. We offer end-to-end impurity research services, such as impurity analysis, forced degradation studies, and impurity identification and structural elucidation.

Trusted by the Pharmaceutical Companies

We are proud that our products have been instrumental in helping numerous pharmaceutical companies overcome impurity-related challenges in development and manufacturing, and ultimately delivering safer and more effective drugs to patients.

Lisa R., Purchasing Director

Impurity reference standard procurement used to drain 30% of our team’s time on vendor vetting. Since partnering with Protheragen Impurity, their dedicated supply chain team guarantees on-time delivery of high-purity standards, even for rare metabolites. We’ve eliminated costly production delays caused by impurity sourcing. For any team prioritizing supply chain resilience and cost control, Protheragen Impurity is the definitive partner.

Lisa R., Purchasing Director

Dr. Alex W., Drug Development Scientis

During the impurity profiling phase of our drug development, we hit a roadblock with a particularly elusive degradation product. Protheragen Impurity didn't just supply the high-purity standard we needed; their scientific team collaborated with us, providing the impurity's formation pathway under various conditions. This depth of technical support was invaluable. They are true scientific partners, not just a provider.

Dr. Alex W., Drug Development Scientist

Sarah T., Quality Assurance Manager

Regulatory compliance is non-negotiable for us. Protheragen Impurity's Certificates of Analysis are unparalleled in their detail and accuracy, making our audit preparations and regulatory submissions significantly smoother. Every impurity standard we've purchased from them is fully traceable and meets the compendial requirements. Their rigorous quality systems were a key factor in our successful passage of a recent FDA pre-approval inspection.

Sarah T., Quality Assurance Manager

Mark R., Formulation Scientist

When we reformulated a legacy product, we encountered unexpected excipient-API interactions that generated new impurities. Protheragen Impurity rapidly synthesized and delivered these novel impurity standards, which were crucial for us to develop a new analytical method and establish control strategies. Their ability to provide custom solutions on an aggressive timeline allowed us to keep our project on track without compromising on safety or quality.

Mark R., Formulation Scientist

Bruce D., Project Manager

Managing a drug development program requires partners who can keep pace. Protheragen Impurity has been exactly that; their global logistics capabilities ensure that impurity reference standards arrive when and where we need them, whether for our R&D site in the US or our manufacturing partner in Asia. They are a reliable source that de-risks our impurity management process across the entire drug lifecycle.

Daniel L., Project Manager