Additional information on Amoxicillin Related Compound M
Parent drug
Amoxicillin
IUPAC Name
(2S,5R,6R)-6-((2R)-2-(2-Amino-2-(4-hydroxyphenyl)acetamido)-2-((2R,4S)-4-carboxy-5,5-dimethylthiazolidin-2-yl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Disodium Salt
Synonyms
N/A
Description
Amoxicillin Related Compound M is a sodium salt impurity of the aminopenicillin scaffold, assigned molecular formula C24H29N5Na2O8S2 and molecular weight 625.63 g/mol. Its composition indicates a dimeric, sulfur-containing beta-lactam related species rather than a simple oxidative degradant, and it is commonly interpreted within impurity profiles as arising from coupling or rearrangement processes during synthesis, storage, or hydrolytic stress. Because penicillin-derived impurities may exhibit sensitizing or process-related toxicological relevance, its occurrence is evaluated in a structured impurity-control context. Trace level determination generally requires LC-MS/MS, high-resolution LC-MS, and orthogonal ion-pair or HILIC chromatographic separation with diode-array detection.
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