A drug-excipient interaction impurity of bromhexine hydrochloride injection: Structure and formation mechanism elucidation.
J Pharm Biomed Anal
; 247: 116256, 2024 Sep 01.
Article
in En
| MEDLINE
| ID: mdl-38850847
ABSTRACT
A long-term stability study using high performance liquid chromatography (HPLC) revealed an unidentified impurity in the bromhexine hydrochloride injection, which was employed as a mucolytic agent. Investigations into stress degradation and elemental impurities revealed one of the elemental impurities Fe3+ in this injection as the primary generator of these impurities. This impurity, named N-carboxymethyl bromhexine, was a product formed during drug-excipient interaction between bromhexine and tartaric acid with Fe3+. The structure of the impurity was identified through ultra-high-performance liquid chromatography with diode array detector (UHPLC-DAD), liquid chromatograph mass spectrometer (LC-MS). Further, the formation mechanism of the impurity was discussed. Overall, this study elucidates the cause, origin, and mechanism of an unknown impurity in bromhexine hydrochloride injection, providing a basis for quality control for bromhexine hydrochloride injections and drug products containing both amine and tartaric acid.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Bromhexine
/
Drug Contamination
/
Excipients
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2024
Document type:
Article