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*The following content is generated by AI and is for reference only.
Overview
Cyclosporin Impurity D is a critical synthetic reference standard used for quality control of the immunosuppressant cyclosporine. It serves as an identification marker in HPLC analysis to ensure pharmaceutical purity. The compound is defined by its specific stereochemistry and chemical structure.
- Molecular Formula: C62H111N11O12
- CAS Number: 85739-46-0
Application
- Pharmaceutical QC: Used as a system suitability standard in reverse-phase chromatography for drug substance testing.
- R&D: Applied in method development to validate separation efficiency during impurity profiling.
- Regulatory Compliance: Essential for generating stability-indicating data required by FDA and EMA guidelines.
Precautions
- Storage: Maintain at -20°C in a dry, inert atmosphere to prevent degradation.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact as it is a potent biological agent.
- Usage Limit: Strictly for laboratory research only; not intended for human therapeutic use.