Objective  To establish a method to qualitatively identify and quantitatively determine a new impurity from beclomethasone propionate inhalation aerasol.

Methods  Ultra-performance liquid chromatography-Q-exactive orbitrap-mass spectrometry (UPLC-QE-MS) technology and Discovery Studio software were used to identify and predict the toxicity of a new impurity in beclomethasone propionate inhalation aerasol, and the content of this new impurity was determined by UPLC.

Results  The new impurity in beclomethasone propionate inhalation aerasol was polybutylene terephthalate  (PBT) cyclic dimer. Discovery Studio  software predicted that PBT dimer had potential developmental toxicity, with no mutagenicity, no ocular and skin irritancy and no rodent carcinogenicity. The content range of PBT dimer in 9 batches of beclomethasone propionate inhalation aerasol was 20.5-116.6 μg per bottle.

Conclusion  This study can realize the rapid identification and toxicity prediction of the new impurity in the preparation, and provide a theoretical basis for the quality control of the preparation by determining  their content.

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