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*The following content is generated by AI and is for reference only.
Overview
Phenoxymethylpenicillin EP Impurity D is a critical reference standard used for the identification and quantification of degradation products in pharmaceutical analysis. Synthesized via controlled hydrolysis or oxidation pathways, it serves to validate the purity of Penicillin V potassium formulations.
- Molecular Formula: C16H18N2O5S
- CAS Number: 7439-08-3
Application
- Quality Control: Employed in HPLC assays to detect trace impurities during active pharmaceutical ingredient (API) manufacturing.
- Stability Testing: Utilized as an analytical standard to monitor degradation kinetics under various stress conditions.
- Regulatory Compliance: Essential for generating data required by ICH guidelines and EP monographs.
Precautions
- Safety: Handle with appropriate PPE; potential allergen similar to beta-lactams.
- Storage: Maintain at -20°C in a desiccated environment away from light.
- Limits: Strictly for research use only; not intended for human or veterinary therapeutic administration.