Development of a new certified reference material of tinidazole for quality and safety of agro-products

s Two independent approaches involving mass balance (MB) method and quantitative nuclear magnetic resonance (qNMR) technique were employed to measure the purity of a new certified reference material (CRM) of tinidazole. The mass fraction of pure tinidazole CRM was assigned to be 99.7 % with an expan...

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Veröffentlicht in:Accreditation and quality assurance 2016-10, Vol.21 (5), p.341-349
Hauptverfasser: Yang, Mengrui, Wang, Min, Zhou, Jian, Song, Yinqing, Wang, Tongtong
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Sprache:eng
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Zusammenfassung:s Two independent approaches involving mass balance (MB) method and quantitative nuclear magnetic resonance (qNMR) technique were employed to measure the purity of a new certified reference material (CRM) of tinidazole. The mass fraction of pure tinidazole CRM was assigned to be 99.7 % with an expanded uncertainty of 0.6 % ( k  = 2). Sample preparation, qualitative analysis, certifying methods optimization, characterization, homogeneity testing, stability monitoring, and uncertainty evaluation were systemically and comprehensively studied in development of tinidazole CRM. The results indicate that the CRM is homogenous and stable at 4 °C for at least 6 months which satisfy the requirements of CRM. The new CRM (GBW(E)090756) can be applicable to instrument calibration and analytical method validation, especially for assurance of accuracy result of tinidazole determination in the program of nationwide routine monitoring and risk assessment for agro-products by Ministry of Agriculture (MOA) in China.
ISSN:0949-1775
1432-0517
DOI:10.1007/s00769-016-1221-0