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Overview
Rosuvastatin EP Impurity G (Calcium Salt) is a specific degradation product of rosuvastatin calcium, utilized for pharmaceutical quality control. Synthesized via controlled oxidation or hydrolysis pathways during API manufacturing, it serves as a reference standard. Its molecular formula is C25H28CaF2N2O6S and CAS number is 147093-94-3.
Application
- Quality assurance in statin production lines.
- Method validation for HPLC and LC-MS analysis.
- Regulatory compliance testing per ICH Q3B guidelines.
Precautions
Store under inert atmosphere at 2-8°C to prevent degradation. Handle with PPE in ventilated areas; avoid inhalation or skin contact due to potential toxicity associated with statin impurities.