AI Article Synopsis
- A long-term stability study using HPLC found an unknown impurity in bromhexine hydrochloride injection, a medication used to help clear mucus.
- Investigations identified that an elemental impurity, iron (Fe), was responsible for forming this impurity, called N-carboxymethyl bromhexine, due to interactions between bromhexine and tartaric acid.
- Advanced techniques like UHPLC-DAD and LC-MS were used to determine the structure of the impurity, ultimately leading to better understanding and control of product quality in bromhexine injections and similar formulations.
Article 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 Fe 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 Fe. 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.
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| http://dx.doi.org/10.1016/j.jpba.2024.116256 | DOI Listing |
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