Reference Material for Testing[2]
Overview
Reference Material for Testing, known as Certified Reference Material (CRM) in ISO terminology, provides metrological traceability for analytical measurements. These materials are homogeneous and stable, with assigned property values validated through rigorous testing. They serve as benchmarks for laboratories to ensure data comparability across instruments, locations, and time periods. In regulatory environments such as FDA or EPA compliance, their use is often mandatory for method validation. The global market is dominated by providers like NIST, LGC, and IRMM, who issue materials with certificates detailing uncertainty and measurement traceability to international standards (e.g., SI units).
Physical and Chemical Properties
The properties vary significantly by material type. For elemental analysis, metallic alloys or salt solutions with precisely known compositions are common. Organic CRMs may include pesticide mixtures or pharmaceutical compounds in specific matrices. Key characteristics include long-term stability (typically 1-5 years), homogeneity at the required measurement scale (e.g., <1% RSD for microanalysis), and inert packaging to prevent contamination. Physical forms range from gas cylinders (for environmental monitoring) to freeze-dried biological materials. Most chemical CRMs have purity levels exceeding 99%, with impurities quantitatively characterized. Storage stability is critical—many require protection from light, moisture, or oxygen to maintain certified values.
Main Applications
Primary applications include calibration of analytical instruments (e.g., ICP-MS, HPLC), where they establish measurement curves. In method validation, they determine accuracy (through recovery tests) and precision (via repeated measurements). Proficiency testing programs distribute blinded CRMs to assess laboratory performance. Industry-specific uses encompass pharmaceutical potency testing (per ICH Q2), environmental pollutant quantification (EPA methods), and food allergen detection. Recent growth areas include cannabis potency testing and nanoparticle characterization. Clinical diagnostics rely heavily on human-matrix-based CRMs for biomarker assays.
Safety and Storage
Safety protocols depend on the CRM's chemical hazards—some inorganic standards contain toxic metals (e.g., cadmium, mercury), while organic solvents require flammability precautions. Material Safety Data Sheets (MSDS) must accompany hazardous CRMs, detailing PPE requirements (e.g., gloves for carcinogenic compounds). Proper storage is essential for maintaining certification. Liquid standards often require refrigeration (2-8°C), while hygroscopic powders need desiccators. Laboratories should document storage conditions and monitor expiry dates, as recertification after expiration requires costly verification testing. Transport regulations (e.g., IATA) apply for hazardous materials shipped internationally.
B2B Procurement Guide
When procuring CRMs, buyers should confirm the material's fitness for purpose—check the certified property matches the intended analysis (e.g., elemental concentration vs. isotopic ratio). Accreditation to ISO 17034 (formerly ISO Guide 34) is mandatory for producers, while ISO/IEC 17025 accreditation is preferred for supplier laboratories. Batch-specific certificates should provide measurement uncertainty (typically 1-3% for major components). Consider purchasing smaller quantities with higher frequency to avoid stability issues. For regulated industries, ensure the CRM is listed in applicable pharmacopeias (USP, EP) or environmental method compendiums. Group purchasing organizations often negotiate volume discounts for common standards.
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