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Minimize risks with effective impurity and contamination control
Using advanced methods and an expert team, we offer comprehensive solutions to identify impurities and contaminants that threaten product efficacy and safety.
Unique combination of benefits
- Dedicated experts, equipment, and infrastructure for all impurity types and classes
- Extensive experience with hundreds of new chemical entities (NCE)/new biological entities (NBE) across modalities, drug substances, products, and dosage forms
- Broad panel of validated platform methods for quick responses in early development or troubleshooting
- Proven track record of developing thousands of validated, phase-appropriate methods for late-stage and commercial release
Comprehensive service solutions
From initial profiling to commercial control strategy, we provide a full suite of impurity and contamination control services:
We provide rapid nitrosamine screening and development/validation of control methods for small nitrosamines, nitrosamine drug substance related impurities (NDSRIs), and any other genotoxic impurities with unparalleled sensitivity and selectivity.
We utilize state-of-the-art instrumentation to detect elemental impurities at the lowest possible levels, ensuring drug safety and regulatory compliance.
We offer expert testing and consulting services for extractables and leachables. Learn more about our E&L services
Based on our extensive portfolio of available platform methods for over 50 different PRIs and utilizing advanced detection methods, we can provide a fast and effective solution for control of process-related impurities.
Using state-of-the-art equipment and techniques, we accurately measure and analyze the levels of residual solvents in your drug products.
We perform profiling of impurities and degradation products, for unknown impurities (including structure elucidation and quantification) at trace levels in drug substance and drug product.
We offer particulate matter characterization and control services spanning the nanometer to millimeter range. Using a comprehensive panel of orthogonal techniques, our experts address issues from protein aggregation through extraneous matter contamination ensuring the safety and efficacy of your drug product.
Contact us for a complimentary consultation
