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*The following content is generated by AI and is for reference only.
Overview
Loxoprofen Impurity 30 is a critical synthetic intermediate in the pharmaceutical manufacturing of Loxoprofen sodium. This chiral impurity arises primarily during the asymmetric hydrogenation or resolution steps of the active pharmaceutical ingredient (API) synthesis. Its precise identification is vital for quality control to ensure compliance with ICH guidelines regarding genotoxic potential.
Molecular Formula: C14H17NO2
CAS No.: 69582-38-9
Application
- Pharmaceutical R&D: Used as a reference standard for method development and validation in HPLC analysis.
- Quality Control: Essential for establishing acceptance limits and monitoring batch purity during API production.
- Toxicological Studies: Serves as a control substance in safety assessments for residual impurities.
Precautions
- Safety: Handle in a fume hood with appropriate PPE; avoid skin contact and inhalation.
- Storage: Store under inert atmosphere at 2-8°C away from light and moisture.
- Regulatory: Strictly limit levels in final drug products based on daily dosage thresholds.