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2015 Fiscal Year Final Research Report

Improvement of the method for detection of falsified medicines using impurity profiling

Research Project

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Project/Area Number 26870220
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Environmental and hygienic pharmacy
Research InstitutionKanazawa University

Principal Investigator

YOSHIDA Naoko  金沢大学, 薬学系, 助教 (20565428)

Research Collaborator SANADA Tomoko  
Project Period (FY) 2014-04-01 – 2016-03-31
Keywords偽造医薬品 / 不純物プロファイル
Outline of Final Research Achievements

I wished to improve the accuracy of detection of falsified medicines. Impurity analyses were undertaken to detect falsified samples of Cialis(R) and compared with other analytical methods. Out of 41 samples, all falsified samples of Cialis(R) (n=32) were defined as “falsified medicine” by impurity profiling. These falsified samples of Cialis(R) could be categorized broadly into seven types according to the nature and amount of ingredients. Physical appearance (color, size, weight), Raman spectra (obtained from the tablet surface) and near-infrared spectrum (obtained from the whole tablet) of falsified samples of Cialis(R) were different from authentic samples. These findings suggest that impurity profiling could be a useful method for detection of falsified medicines in pharmaceutical distribution.

Free Research Field

医療薬学、国際保健薬学

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Published: 2017-05-10  

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