*The following content is generated by AI and is for reference only.
Overview
Iohexol Hydrolysate is a degradation product of the non-ionic X-ray contrast agent Iohexol, generated via acid or enzymatic hydrolysis. It serves as an impurity standard for quality control in pharmaceutical manufacturing.
- Molecular Formula: C19H26I3N3O8
- CAS Number: 76570-82-4
Application
- Pharmaceutical Analysis: Used as a reference standard to identify and quantify related substances in Iohexol bulk drugs during stability testing.
- Method Validation: Employed to calibrate HPLC systems for ensuring compliance with ICH Q3B guidelines on impurities.
- Quality Assurance: Critical for batch release testing to verify the purity profile of radiopharmaceutical formulations.
Precautions
- Storage: Maintain at -20°C in a dry, inert atmosphere to prevent further degradation.
- Safety: Handle with appropriate PPE; avoid direct contact as it may cause skin irritation.
- Usage: Strictly for analytical research only; not approved for clinical administration or therapeutic use.