Analysis of ICH-Q3D Endorsed Elemental Impurities in Macrolide Antibiotics by ICP-MS
Ravisankar Mathesan,
Alexandar Sekar,
Senthil Kumar Raju
et al.
Abstract:Aim:The objective of this study was to determine the amount of twenty-three elemental impurities in Azithromycin API. A rapid, selective, precise, accurate and sensitive approach for detecting elemental impurities in Azithromycin API was developed and validated using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). Background: Conventional analytical methods used in pharmacopoeia's are less sensitive and accurate to detect heavy metal impurities. Concerning this issue, a new inductively coupled plasma ma… Show more
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