title: Development of a new certified reference material of diosgenin using mass balance approach and Coulometric titration method.
abstract: Certified reference materials (CRMs) can be used as a valuable tool to validate the trueness of measurement methods and to establish metrological traceability of analytical results. Diosgenin has been selected as a candidate reference material. Characterization of the material relied on two different methods, mass balance method and Coulometric titration method (CT). The certified value of diosgenin CRM is 99.80% with an expanded uncertainty of 0.37% (k=2). The new CRM of diosgenin can be used to validate analytical methods, improve the accuracy of measurement data and control the quality of diosgenin in relevant pharmaceutical formulations.
authors.affiliation: Beijing Key Laboratory of Polymorphic Drugs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China.
authors.forename: Ningbo
authors.initials: N
authors.lastname: Gong
authors.affiliation: Beijing Key Laboratory of Polymorphic Drugs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China.
authors.forename: Baoxi
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Beijing Key Laboratory of Polymorphic Drugs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Hu
authors.affiliation: Beijing Key Laboratory of Polymorphic Drugs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Du
authors.affiliation: Beijing City Key Laboratory of Drug Target Identification and Drug Screening, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China. Electronic address: dugh@imm.ac.cn.
authors.forename: Guanhua
authors.initials: G
authors.lastname: Du
authors.affiliation: Key laboratory of Polymorph Pharmaceutical of Shandong Province, Tengzhou 277500, China.
authors.forename: Zhaolin
authors.initials: Z
authors.lastname: Gao
authors.affiliation: Beijing Key Laboratory of Polymorphic Drugs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China; Key laboratory of Polymorph Pharmaceutical of Shandong Province, Tengzhou 277500, China. Electronic address: luy@imm.ac.cn.
authors.forename: Yang
authors.initials: Y
authors.lastname: Lu
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004144:Diosgenin / Q000032:analysis*; D012015:Reference Standards
chemical_list: D004144:Diosgenin
keywords: Certified reference materials; Coulometric titration; Diosgenin; High performance liquid chromatography