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BS ISO 33407:2024

$198.66

Guidance for the production of pure organic substance certified reference materials

Published By Publication Date Number of Pages
BSI 2024 52
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Technical and production requirements
4.1 General
4.2 Production planning
4.3 Specification of the CRM and its measurand
4.3.1 General
4.3.2 Specification of purpose
11 4.3.3 Specification of the measurand
4.3.4 Definition of the metrological reference
4.3.5 Fitness for purpose
12 4.3.6 Safety considerations
4.3.7 Resources and approaches to purity analysis
4.4 Candidate material sourcing and assessment of suitability, including verification of PC identity and adequate purity
4.4.1 Material sourcing
4.4.2 ​Verification of PC identity
13 4.4.3 Material suitability
4.5 Product packaging and specification of conditions for storage and safe handling
4.5.1 General considerations
14 4.5.2 Selection and treatment of packaging materials
4.5.3 Storage and transportation issues
4.5.4 Label of containers
15 4.6 Determination of approaches to purity assessment of the CRM
16 4.7 Development and validation of procedures for characterization, including achieving target measurement uncertainty
4.7.1 General
4.7.2 Multiple methods for purity determination
17 4.7.3 Property value boundaries
4.8 ​Assessment of homogeneity
4.8.1 General
4.8.2 Preliminary assessment of homogeneity
4.8.3 Sampling strategy
18 4.8.4 Minimum sample size
4.8.5 Experimental method of homogeneity assessment
4.9 ​Assessment and monitoring of stability
4.9.1 General
4.9.2 Sources of instability
4.9.3 Repeated use stability
19 4.9.4 Stability monitoring
4.10 Characterization of the CRM
4.10.1 General
4.10.2 Direct determination
4.10.3 Indirect determination
20 4.10.4 Characterization for use in multi-component solutions
4.11 Metrological traceability of the certified property value
4.12 Preparation of certificates
22 Annex A (informative) Examples of structure identification approaches
24 Annex B (informative) Examples of measurement procedures for assessment of purity
28 Annex C (informative) Examples of production of pure substance organic certified reference materials by reference material producers
49 Bibliography
BS ISO 33407:2024
$198.66