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*The following content is generated by AI and is for reference only.
Overview
Terbutaline Impurity 27 is a synthetic pharmaceutical reference standard used for quality control in beta-agonist production. It serves as a critical marker for identifying degradation products during synthesis and storage. The compound typically features the molecular formula C12H19NO3 with CAS number 68047-52-5.
Application
- Quality Assurance: Validated by HPLC to detect trace impurities in bulk drug substances.
- R&D Support: Utilized in stability-indicating method development for Terbutaline sulfate formulations.
- Regulatory Compliance: Essential for dossier submissions to FDA and EMA regarding impurity profiling.
Precautions
- Storage: Maintain at -20°C in airtight, light-resistant containers to prevent hydrolysis.
- Safety: Handle with nitrile gloves; avoid inhalation of dust particles in non-ventilated areas.
- Usage: Strictly for analytical research purposes only; not intended for clinical administration.