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Study on Isomeric Impurities in Cefotiam Hydrochloride.

Ye Tian¹, Xiao-Meng Chong¹, Ying Liu¹

¹National Institutes for Food and Drug Control, Beijing, China.

Frontiers in Chemistry

|February 15, 2021

Summary

Two isomeric impurities in cefotiam hydrochloride injection were identified as Δ3(4) isomers. Software analysis predicted these impurities are not embryotoxic, aiding cefotiam quality control.

Keywords:

HPLC-MS cefotiam hydrochloride column switching isomer nuclear magnetic resonance

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Published on: August 30, 2018

Area of Science:

Pharmaceutical Chemistry
Analytical Chemistry
Toxicology

Background:

Cefotiam hydrochloride is an antibiotic used in injections.
Ensuring the purity of pharmaceutical preparations is critical for patient safety.
Identification and characterization of impurities are essential for quality control.

Purpose of the Study:

To identify and characterize isomeric impurities in cefotiam hydrochloride injection.
To assess the potential embryotoxicity of the identified impurities.
To provide data supporting the quality control of cefotiam production and storage.

Main Methods:

Utilized column-switching High-Performance Liquid Chromatography coupled with Mass Spectrometry (HPLC-MS).
Employed Nuclear Magnetic Resonance (NMR) spectroscopy for structural elucidation.
Conducted software-based calculations to predict toxicological profiles.

Main Results:

Two specific isomeric impurities were identified and characterized as Δ3(4) isomers of cefotiam.
Computational analysis indicated that neither identified impurity poses an embryotoxic risk.
The findings establish a basis for monitoring these impurities in cefotiam hydrochloride.

Conclusions:

The Δ3(4) isomers of cefotiam were confirmed as impurities in the injection preparation.
The identified impurities are predicted to be non-embryotoxic, suggesting a favorable safety profile.
This research offers valuable insights for the manufacturing, handling, and quality assurance of cefotiam and similar cephalosporin antibiotics.