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*The following content is generated by AI and is for reference only.
Overview
Cyclosporin Impurity C is a critical reference standard used in pharmaceutical quality control. It serves as an identification and quantification tool for the immunosuppressant drug cyclosporine during manufacturing. The molecular formula is C62H111N11O12 with CAS No. 95827-06-4. This compound typically arises from synthetic side reactions or degradation pathways.
Application
- Quality Assurance: Employed in HPLC method validation to detect trace levels in bulk API.
- R&D Analysis: Used to monitor reaction kinetics and optimize purification processes.
- Regulatory Compliance: Essential for generating stability data required by FDA and EMA submissions.
Precautions
- Storage: Maintain at -20°C in sealed, inert atmosphere containers to prevent degradation.
- Safety: Handle in fume hoods; wear PPE including gloves and goggles due to potential toxicity.
- Usage: Strictly for analytical purposes only; not intended for clinical administration.