Founded in 2014, Guangzhou Junmu Biotechnology Co., Ltd. is a high-tech enterprise integrating pharmaceutical research and development, biotechnology services (raw and auxiliary material production) and marketing. The company strictly follows the ISO9001 and CNAS management system for product quality management, and passed the on-site inspection of the China Institute for Food and Drug Control in 2042 and officially became a supplier of reference materials and raw materials.
*The following content is generated by AI and is for reference only.
Overview
Cefradine Impurity B is a critical reference standard used in pharmaceutical quality control for the cephalosporin antibiotic Cefradine. Synthesized via oxidation of the side chain, it serves to validate purity profiles during manufacturing.
Molecular Formula: C16H17N3O5S
CAS Number: 20894-36-4
Application
- Quality Assurance: Used as an analytical standard to identify and quantify degradation products in finished drug substances.
- R&D Testing: Employed in stability studies to monitor impurity formation under various stress conditions.
- Regulatory Compliance: Supports documentation for FDA and EMA submissions regarding impurity thresholds.
Precautions
- Storage: Keep sealed in a cool, dry place below 25°C away from light.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential sensitization.
- Usage: For laboratory use only; not intended for direct clinical administration.