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Overview
Faropenem Impurity 13 is a critical reference standard for the quality control of the carbapenem antibiotic Faropenem. It serves as an essential marker in identifying degradation products during synthesis and storage. The molecular formula is C14H20N2O5S, with CAS number 269758-35-4.
Application
- Pharmaceutical QC: Used in HPLC method validation to detect trace impurities in bulk drug substances.
- R&D Studies: Applied in stability-indicating studies to monitor degradation pathways under stress conditions.
- Regulatory Compliance: Essential for generating data required by FDA and EMA guidelines on impurity profiling.
Precautions
- Storage: Must be stored at -20°C in airtight containers protected from light and moisture.
- Handling: Requires PPE due to potential sensitization; avoid inhalation or skin contact.
- Usage: Strictly for research purposes only; not intended for clinical administration.