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Overview
Aztreonam USP Related Compound E, also known as E-Aztreonam, is a critical reference standard used for impurity profiling in the pharmaceutical industry. It serves as a key degradation product identified during the synthesis and stability testing of the monobactam antibiotic Aztreonam. The compound features a distinct stereochemical configuration essential for accurate chromatographic separation. Its molecular formula is C13H17N5O8S2, with CAS number 109496-04-6.
Application
- Quality Control: Used as an analytical standard to quantify specific impurities in bulk drug substances under ICH guidelines.
- R&D: Employed in method development to validate HPLC separation efficiency for Aztreonam formulations.
- Regulatory Compliance: Supports stability-indicating studies required for FDA and EMA registration dossiers.
Precautions
Storage must be maintained at -20°C in a dry, dark environment to prevent hydrolysis. Personnel handling this substance require appropriate PPE due to potential sensitization risks. Clinical use is restricted strictly to laboratory analysis; it is not intended for therapeutic administration.