Resources
Detailed Certificate of Analysis
Preview the components and layout of an Aurum CofA
ICH Quality Guidelines Overview
ICH Q2: Analytical Method Validation
FDA-recognized guidance defining requirements for accuracy, precision, and specificity of analytical methods, supported by appropriately qualified and traceable reference standards. FDA allows the use of non-compendial reference standards when they are fully characterized, suitable for their intended use, and supported by appropriate documentation and traceability.
EMA Quality Guidelines (EU Regulatory Framework)
European regulatory guidance on specifications, analytical procedures, and quality requirements for pharmaceutical materials.
ISO 17034: Reference Material Production
International standard outlining requirements for the competence and operation of reference material producers.
ISO/IEC 17025: Measurement Traceability
Requires all analytical results to be traceable to recognized standards through documented calibration chains, including the use of certified or otherwise qualified reference materials.
Accreditation Status
Aurum Standards Group is actively pursuing accreditation to internationally recognized quality standards, including ISO 17034 for reference material producers and ISO/IEC 17025 for testing and calibration laboratories.
Our quality management system has been developed in alignment with the requirements of these standards from the outset, with a strong focus on traceability, measurement uncertainty, homogeneity, stability, and technical competence. We are currently in the final stages of implementation and assessment.
We anticipate formal accreditation in mid-2026, at which time full details, including scope of accreditation and certificate documentation, will be made available.
In the interim, Aurum operates under a rigorously controlled quality framework designed to ensure the reliability, consistency, and scientific integrity of all materials produced. Supporting documentation, including Certificates of Analysis and technical reports, is generated in accordance with applicable ISO guidance and industry best practices.
For questions regarding our quality system or accreditation timeline, please contact our team at [email protected].
What's the difference between ISO 17034 and ISO/IEC 17025?
Is Aurum Standards Group GMP certified?
No, and for analytical standards, that’s by design. GMP governs pharmaceutical manufacturing; our materials are built for testing, method development, and quality control. What matters for that work is traceability, consistency, and documentation, and we maintain those rigorously through controlled procedures, trained analysts, qualified equipment, and complete recordkeeping.
How are Aurum standards traceable?
Every value we report is linked to recognized reference points, including NIST reference materials, USP standards, and other pharmacopeial references where applicable. We achieve this through validated methods, calibrated equipment, and controlled records, so the numbers on your certificate aren’t just measured, they’re defensible.
How is shelf life determined?
We don’t guess at expiration dates. We support them with data. Shelf life is established using stability data, the chemistry of the analyte, solvent compatibility, packaging configuration, and historical performance, with conservative dating to help ensure material performs as certified throughout its assigned life.
Where can I find SDSs and COAs?
Both are available through the product page or upon request. COAs provide lot-specific identification, assigned values, and supporting analytical data for the material you received. SDSs provide information on safe handling, storage, and disposal. Need help tracking one down? Contact us and we’ll be happy to assist.
