Product Name: Impurity of Paricalcitol from API broken down by oxidation -1
CAS No.:
Quality Standard: Enterprise standard, content NLT 95%
Main Application: Impurity of Paricalcitol API
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Overview
Paricalcitol oxidation impurity is a critical degradation product formed via photo-oxidation or thermal stress during synthesis. It serves as an essential reference standard for validating the purity of active pharmaceutical ingredients (APIs). Molecular formula: C27H40O3; CAS No.: 195386-37-5.
Application
- Quality Control: Used in HPLC method validation to detect trace oxidized byproducts in Paricalcitol bulk drugs.
- R&D Stability: Employed in forced degradation studies to assess formulation shelf-life under oxidative conditions.
- Regulatory Compliance: Required for ICH Q3B documentation to establish acceptable limits in drug substance specifications.
Precautions
Store strictly at -20°C in amber vials under inert atmosphere to prevent further degradation. Handle with appropriate PPE due to potential mutagenicity; avoid direct skin contact and inhalation of dust particles.