Description

Cefradine Impurity 5 is a specified impurity of the first-generation cephalosporin antibiotic, Cefradine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical laboratories and pharmaceutical manufacturers to ensure the purity, safety, and efficacy of Cefradine API and its finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefradine Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance: A critical component in QC laboratories to establish specification limits and ensure batch-to-batch consistency of Cefradine in compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity profiles and determine the shelf-life of pharmaceutical products.
• Regulatory Submissions: Required for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to study degradation pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Product Name	Cefradine Impurity 5
CAS No.	1379292-16-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefradine Related Compound 5; Cephradine Impurity 5; (6R,7R)-7-[[(2R)-Amino-2-(1,4-cyclohexadien-1-yl)acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2R)-amino-2-(1,4-cyclohexadien-1-yl)acetyl]amino]-3-methyl-8-oxo-, (6R,7R)-; Cefradine Degradant; Cephradine EP Impurity C
EINECS	Contact for details

Quality Control

Our Cefradine Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.