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*The following content is generated by AI and is for reference only.
Overview
Ampicillin EP Impurity E, chemically known as Penicilloic acid ampicillin, is a critical degradation product monitored during the synthesis and stability testing of ampicillin. This impurity arises from the hydrolysis of the beta-lactam ring under acidic or basic conditions. Its molecular formula is C16H20N2O7S, and it is identified by CAS number 4568-23-2.
Application
- Quality Control: Used as a reference standard to validate HPLC methods for detecting related substances in pharmaceutical batches.
- Stability Studies: Employed to assess the shelf-life and degradation pathways of ampicillin formulations under various storage conditions.
- R&D: Applied in process optimization to minimize impurity formation during large-scale manufacturing.
Precautions
- Storage: Maintain at -20°C in a dry, inert atmosphere to prevent hydrolysis.
- Safety: Handle with PPE; potential allergen similar to penicillins.
- Usage: Strictly for laboratory analysis; not for human or veterinary therapeutic use.