Traceability of measurement results in chemistry: a case study of certification of three new pharmaceutical reference materials

Nogueira, Raquel Fernandes Pupo; Silva, Gisele E. B.; Queiroz, Suzane M.; Mello, Monique G.; Rocha, Wérickson Fortunato de Carvalho

doi:10.1007/s00769-012-0918-y

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Mass Balance Approach1

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“…For most of metals (elements) and gases, it is the only practical measure for purity assessment. The method is also commonly used to assess purity of organic materials [15][16][17][18][19][20]. The 'purity' of commercial reagents expressed as 'GC%' or 'LC%' is given by a simple version of this approach.…”

Section: Mass Balance Approachmentioning

confidence: 99%

Conventional and new traceability schemes of organic standards for safe water supply in Japan

et al. 2019

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Metrological traceability to the International System of Units (SI) is required to ensure reliability of analytical results. For this purpose, SI-traceable standard solutions of respective analytes are essential for common analytical methods such as chromatography. However, it is not so easy to fulfill demands due to the existence of a vast number of targets, especially in the case of organic analysis. Because high-purity organic materials which are raw materials of standard solutions must be characterized by compound-independent methods, the mass balance approach (subtraction method) and the primary methods of measurement (e.g. the freezing point depression method and titrimetry) are used. Recently, quantitative NMR (qNMR) has been popularized.

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