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Identification of Impurities in Norvancomycin Hydrochloride Drug Substance Using UHPLC-QTOF-MS
Yanni Liu1, Jinqi Zheng2, Jia Sun1
1Key Laboratory for Green Pharmaceutical Technologies and Related Equipment of Ministry of Education, College of Pharmaceutical Sciences, Zhejiang University of Technology, Hangzhou, Zhejiang, China.
Rapid Communications in Mass Spectrometry : RCM
|August 9, 2026
Summary
This study identified thirteen impurities and two degradation products in Norvancomycin (NVCM) hydrochloride using UHPLC-QTOF-MS. The findings provide a reference method for NVCM hydrochloride quality control.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Science
Background:
- Norvancomycin (NVCM) hydrochloride is a glycopeptide antibiotic effective against Gram-positive bacteria.
- Drug quality is critical for patient safety, and impurities significantly impact drug quality.
- Investigating the impurity profile of NVCM hydrochloride is essential for ensuring its therapeutic efficacy and safety.
Purpose of the Study:
- To develop and validate a sensitive analytical method for identifying and characterizing impurities in Norvancomycin (NVCM) hydrochloride.
- To elucidate the chemical structures of impurities and degradation products present in NVCM hydrochloride samples.
Main Methods:
- Ultrahigh performance liquid chromatography quadrupole-time-of-flight mass spectrometry (UHPLC-QTOF-MS) was employed for impurity profiling.
- A C18 chromatographic column was utilized with a gradient elution system involving ammonium formate and methanol.
- Stress degradation studies were performed to assess the method's specificity.
Main Results:
- A total of thirteen impurities and two degradation products were successfully identified and characterized.
- The UHPLC-QTOF-MS method demonstrated high sensitivity and specificity for detecting NVCM hydrochloride impurities.
Conclusions:
- The chemical structures of the identified impurities were elucidated using MS/MS spectral data and exact mass measurements.
- This study establishes a valuable reference method for the quality control of Norvancomycin (NVCM) hydrochloride, ensuring drug safety and efficacy.
