Overview
ISO 33407:2024 - Guidance for the production of pure organic substance certified reference materials (CRMs) - provides recommendations for the technical production and characterization of CRMs made from defined organic compounds. Published by ISO in 2024, this document complements ISO 17034 by focusing on CRMs that are single, non‑polymeric organic substances used to calibrate instruments and establish metrological traceability. The standard covers planning, verification of primary component identity and purity, packaging, stability and homogeneity assessment, and assignment of certified purity values.
Key topics and requirements
The standard addresses practical production steps and technical requirements, including:
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Specification and purpose
- Define intended use, measurand, target purity and target measurement uncertainty.
- Identify the metrological reference and fitness‑for‑purpose considerations.
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Candidate material sourcing and identity
- Verify the primary component (PC) identity and assess material suitability and adequate purity before production.
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Purity assessment and characterization
- Determine appropriate approaches to purity assessment.
- Develop and validate procedures to achieve the target measurement uncertainty.
- Use multiple methods where appropriate for robust characterization.
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Homogeneity and stability
- Plan and execute sampling strategies and experiments to assess between‑unit homogeneity.
- Identify sources of instability, monitor stability over time, and consider repeated‑use effects.
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Packaging, storage and safety
- Select suitable packaging materials, specify storage and transport conditions, and label containers with handling and safety information.
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Traceability and documentation
- Ensure metrological traceability of the certified property value and prepare comprehensive certificate(s) describing the CRM, its uncertainty, and usage instructions.
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Supporting material
- Informative annexes provide examples of structure identification, measurement procedures for purity assessment, and examples of CRM production.
Applications and users
ISO 33407:2024 is intended for:
- Reference material producers (RMPs) who design and manufacture pure organic substance CRMs.
- Accreditation bodies and laboratories implementing ISO 17034 and seeking CRM‑specific guidance.
- Calibration and testing laboratories needing high‑quality CRMs for instrument calibration, method validation, and establishing metrological traceability.
- Regulatory and quality managers in chemical, pharmaceutical, environmental and food testing sectors.
Practical applications include production and certification of high‑purity organic standards used for calibration, method development, interlaboratory comparisons and quality assurance.
Related standards
- ISO 17034 - General requirements for the competence of reference material producers (mandatory context).
- ISO Guide 30, ISO/IEC 17000, ISO/IEC Guide 99 and ISO 9000 - referenced for terminology, metrology principles and quality management.
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