API Impurities
High-quality reference standards for known and unknown impurities to support your analytical methods, quality control, and regulatory compliance.
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Available Impurity Standards
Need a Custom Impurity Standard?
Our team can synthesize custom API impurity standards to your specifications for method development, validation, and regulatory submissions.
Custom Synthesis
Tailor-made impurity standards for your specific needs
- Synthesis of non-commercially available impurities
- Multi-step synthesis capabilities
- Milligram to gram scale production
- Full analytical characterization
Method Development
Support for your analytical method needs
- Impurity profiling
- Separation method development
- Method validation support
- Stability-indicating method development
Documentation Support
Comprehensive certification for regulatory compliance
- Certificate of Analysis (CoA)
- Full spectral data package
- Stability data
- GMP documentation where required
