Description

Cefradine Impurity 8 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 in the analytical characterization and quality control of Cefradine drug substances and finished products. It is primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical industry to ensure product safety, efficacy, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefradine Impurity 8 in drug substance and drug product analysis.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC) methods.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure Cefradine batches meet the specifications of pharmacopeias like USP, EP, and BP.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Cefradine, leading to improved formulation and packaging strategies.

Basic Information

Product Name	Cefradine Impurity 8
CAS No.	30959-67-2
Molecular Formula	C16H19N3O4S
Molecular Weight	349.41 g/mol
Synonyms	(6R,7R)-7-[[(2R)-Amino(cyclohexa-1,4-dien-1-yl)acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cephradine Impurity 8; Cefradine Related Compound 8; Cephradine Related Compound 8; Cefradine EP Impurity 8; Cephradine USP Impurity 8; 7-[(Cyclohexa-1,4-dien-1-ylglycyl)amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Cefradine Impurity 8 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided for every batch to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to Off-white Powder
Identification (IR)	Conforms to Reference Spectrum
Identification (HPLC)	Retention time corresponds to Reference Standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C Guidelines

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