Certified reference materials (CRM)
Impurities and API-related CRMs with certified property values, measurement uncertainty and metrological traceability — produced or distributed under principles aligned with ISO 17034 for method validation and lab accreditation.
17034
producer framework
U (k=2)
uncertainty
SI
traceability aim
CRM
certificate
Shelf life
certified period
Certified value and uncertainty
A CRM certificate states a certified property value (concentration, purity or potency) and an associated uncertainty, typically as expanded uncertainty U with coverage factor k = 2 (approximately 95% confidence) unless the certificate defines otherwise.
Homogeneity and stability studies underpin the certified shelf life. Users apply the CRM for calibration, system suitability and as the anchor for preparing working standards under ISO/IEC 17025.
CRM producer (17034) vs testing lab (17025)
ISO 17034 accreditation covers reference material production: assignment methods, uncertainty budgets, and distribution controls.
ISO/IEC 17025 accreditation covers the laboratory using the CRM: method validation, sample prep and reporting. Possession of a CRM does not by itself make a lab 17034-certified — roles are complementary.
Material grade comparison
| Feature | Attribute | Reagent | Working standard | Compendial | CRM |
|---|---|---|---|---|---|
| Certificate type | COA | WS qualification | Pharmacopeial cert | CRM certificate | |
| Certified uncertainty | — | Sometimes | Where monograph specifies | Yes | |
| Homogeneity study | — | — | Pharmacopeial | Yes | |
| ISO 17034 scope | — | — | — | Yes | |
| Ideal use | Synthesis | Daily QC | Monograph compliance | Calibration & filing anchor |
Typical CRM certificate elements
Certified purity / potency
e.g. 99.8% ± 0.3%
Expanded U on certificate
Traceability
SI or primary method
Stated assignment procedure
Expiry / valid use
Date
Stability protocol referenced
Storage
Controlled conditions
Opened-container guidance if provided
CRM code
Unique identifier
Batch homogeneity unit
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
What you receive
- CRM certificate with certified value and uncertainty
- Safety and storage documentation
- Assignment method summary
- Optional duplicate unit for retention
- Support letter for audit and inspection
Frequently asked questions
CRM status is lot-specific and stated on the certificate. R&D-grade material is available when CRM is not required.
Related
Working Standards
Secondary working standards traceable to primary or certified reference materials — qualified under ISO/IEC 17025-style laboratory practice for daily HPLC, GC and titre use without consuming CRM inventory.
View detailsStable-Isotope Standards
Deuterated and 13C-labeled impurities, metabolites and APIs for isotope dilution quantitation — minimizing matrix suppression effects in bioanalysis and nitrosamine confirmatory methods.
View detailsNitrosamine Impurities
Small-molecule nitrosamines and nitrosamine drug substance-related impurities (NDSRIs) as reference materials for confirmatory testing, CPCA categorization and acceptable intake (AI) justification under current FDA, EMA and ICH M7 expectations.
View detailsOncology Reference Standards
Impurities, degradants and reference standards for cytotoxic and targeted oncology APIs — supporting potency assays, related-substances control and nitrosamine risk assessment in high-potency handling environments.
View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.