Impurity profiling of N,N'-ethylenebis-l-cysteine diethyl ester (Bicisate).
J Pharm Biomed Anal
; 150: 132-136, 2018 Feb 20.
Article
in En
| MEDLINE
| ID: mdl-29223061
ABSTRACT
A HPLC-UV-CAD method with a HILIC column for impurity profiling of the 99mTc chelating agent bicisate has been developed and evaluated. Bicisate and its impurities were separated by means of isocratic elution on a zwitterionic stationary phase using a mixture of 7.5mmol/L trifluoroacetic acid and acetonitrile (47.552.5 V/V) as the mobile phase. Five different bicisate batches of a manufacturer were tested using the method. In addition LC-MS experiments were conducted in order to identify the impurities. The predominant impurities found were the oxidation product (disulfide), the monoester of ethylene dicysteine and an unknown compound with an m/z of 293 in ESI positive mode. A new degradation product of bicisate, bicisate lactam, was identified during sample solution stability assessment.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Organotechnetium Compounds
/
Drug Contamination
/
Chromatography, High Pressure Liquid
/
Radiopharmaceuticals
/
Cysteine
Type of study:
Prognostic_studies
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2018
Document type:
Article
Affiliation country:
Germany