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Estimation of impurity profiles of drugs and related materials Part 15. Identification of minor impurities in cimetidine.

Abstract：

:Besides several known impurities in cimetidine, two additional compounds at levels below 0.1% were detected by ion-pair reversed-phase high-performance liquid chromatography (HPLC). The impurities were isolated from crude cimetidine using normal-phase preparative HPLC. 1H and 13C NMR and mass spectrometric investigations revealed the structures of the impurities to be 2,5-bis[(N'-cyano-N"-methyl)guanidinoethylthiomethyl]-4-methylimid azole (VII) and 1,8-bis[(N'-cyano-N"-methyl)guanidino]-3,6-dithiaoctane (VIII). These structures were verified by synthesis of the impurities and comparison of the spectra and chromatographic (HPLC and TLC) retention data of the isolated and synthesized materials.

journal_name

J Pharm Biomed Anal

journal_title

Journal of pharmaceutical and biomedical analysis

authors

Halmos Z,Szántay C Jr,Brlik J,Csehi A,Varga K,Horváth P,Kislaki M,Domány G,Nemes A,Görög S

doi

10.1016/0731-7085(96)01815-8

subject

Has Abstract

pub_date

1996-10-01 00:00:00

pages

1-5

issue

1

eissn

0731-7085

issn

1873-264X

pii

0731-7085(96)01815-8

journal_volume

15

pub_type

杂志文章

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