Reference Standards
Working/reference standards and certified materials to support analytical qualification and regulatory filings.
Overview
We provide a comprehensive range of working and certified reference standards designed to ensure the highest level of accuracy, reproducibility, and compliance in pharmaceutical analysis.
Each standard undergoes detailed characterisation and qualification using validated analytical methods aligned with ICH, ISO/IEC 17025, and pharmacopoeial requirements. Our reference materials support both routine analytical work and regulatory submissions, providing traceability and confidence across the development and manufacturing lifecycle.
Key Features
- Certified working and reference standards with traceable documentation
- Full characterisation via NMR, MS, HPLC/GC, and elemental analysis
- Batch qualification and stability studies for long-term use
- Regulatory support documentation for global submissions
- Compliance with ICH Q7, Q3A/B, and pharmacopoeial guidelines
Request Your Reference Standards
For catalogue availability, COA, and documentation, please contact our analytical support team.
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