AS/NZS ISO 33407:2024 identically adopts ISO 33407:2024 which specifies the requirements of AS ISO 17034 and provides specific guidance on technical considerations for the production of pure organic substance certified reference materials (CRMs)
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
4.3.3 Specification of the measurand
4.3.4 Definition of the metrological reference
4.3.5 Fitness for purpose
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
4.4.3 Material suitability
4.5 Product packaging and specification of conditions for storage and safe handling
4.5.1 General considerations
4.5.2 Selection and treatment of packaging materials
4.5.3 Storage and transportation issues
4.5.4 Label of containers
4.6 Determination of approaches to purity assessment of the CRM
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
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
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
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
4.10.4 Characterization for use in multi-component solutions
4.11 Metrological traceability of the certified property value
4.12 Preparation of certificates
Annex A
A.1 Considerations for structure identification
A.2 Examples for structure identification methods
A.2.1 General
A.2.2 Mass spectrometry
A.2.3 Nuclear magnetic resonance
A.2.4 Molecular spectroscopy
A.2.5 Chromatography
A.2.6 Other approaches
Annex B
B.1 Preamble
B.2 Direct determination of purity
B.2.1 General
B.2.2 Quantitative nuclear magnetic resonance
B.2.3 Titrimetry
B.3 Indirect determination of purity
B.3.1 General
B.3.2 Mass balance method
B.3.2.1 General
B.3.2.2 Structural related organic impurities
B.3.2.3 Volatile organic impurities
B.3.2.4 Water
B.3.2.5 Inorganics or non-volatile residue
B.3.3 Thermal methods
Annex C
C.1 Preamble
C.2 The certification of the purity of benzo[a]pyrene
C.2.1 Information regarding the example
C.2.2 Sourcing
C.2.3 Identity
C.2.4 Strategies
C.2.5 Assessment of homogeneity
C.2.5.1 Between-vial homogeneity
C.2.5.2 Within-vial homogeneity and minimum sample size
C.2.6 Assessment and monitoring of stability
C.2.6.1 General
C.2.6.2 Short-term stability study
C.2.6.3 Long-term stability study
C.2.6.4 Estimation of uncertainties
C.2.6.5 Additional confirmation of stability
C.2.7 Consideration of metrological traceability
C.2.7.1 Identity
C.2.7.2 Quantity value
C.2.8 Characterization using direct methods
C.2.8.1 qNMR
C.2.8.2 Differential scanning calorimetry
C.2.9 Characterization using indirect methods
C.2.9.1 General
C.2.9.2 Organic impurities
C.2.9.3 Inorganic impurities
C.2.9.4 Residual solvents
C.2.9.5 Summary of mass balance approach
C.2.10 Treatment of non-detects in characterization
C.2.11 Combination of qNMR and mass balance approach
C.2.12 Assignment of property value and uncertainty
C.3 Purity assessment of benzoic acid
C.3.1 Information regarding the example
C.3.2 Sourcing
C.3.3 Identity
C.3.4 Assessment of homogeneity
C.3.5 Assessment and monitoring of stability
C.3.6 Consideration of metrological traceability
C.3.7 Characterization using direct methods
C.3.8 Characterization using indirect methods
C.3.9 Treatment of non-detects in characterization
C.3.10 Combination of methods (to get one property value)
C.3.11 Uncertainty estimation
C.3.12 Combination of data
C.3.13 Assignment of property values
C.3.14 Information in RM document
C.4 Purity assessment of Cystine
C.4.1 Information regarding the example
C.4.2 Sourcing
C.4.3 Identity
C.4.4 Assessment of homogeneity
C.4.5 Assessment and monitoring of stability
C.4.6 Consideration of metrological traceability
C.4.7 Characterization using direct methods
C.4.8 Characterization using indirect methods
C.4.9 Treatment of non-detects in characterization
C.4.10 Combination of methods (to get one property value)
C.4.11 Uncertainty estimation or assignment of property values
C.4.12 Combination of data
C.4.13 Information in RM document
C.5 Certification of 3,5-bis(trifluoromethyl)benzoic acid
C.5.1 Information regarding the example
C.5.2 Sourcing
C.5.3 Identity
C.5.4 Strategies
C.5.5 Assessment of homogeneity
C.5.6 Assessment and monitoring of stability
C.5.6.1 General
C.5.6.2 Consideration of metrological traceability
C.5.7 Characterization using direct methods
C.5.8 Characterization using indirect methods
C.5.9 Treatment of non-detects in characterization
C.5.10 Combination of methods (to get one property value)
C.5.11 Uncertainty estimation
C.5.12 Information in RM document
C.6 Certification of Triphenyl phosphate
C.6.1 Information regarding the example
C.6.2 Sourcing
C.6.3 Identity
C.6.4 Strategies
C.6.5 Assessment of homogeneity
C.6.6 Assessment and monitoring of stability
C.6.7 Consideration of metrological traceability
C.6.8 Characterization using direct methods
C.6.9 Characterization using indirect methods
C.6.10 Combination of methods (to get one property value)
