Description

Cefradine Impurity 8 is a specified impurity of the first-generation cephalosporin antibiotic, Cefradine. This compound is of critical importance for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and ensuring the purity and safety of Cefradine API and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefradine Impurity 8 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure Cefradine batches meet stringent pharmacopoeial specifications (e.g., USP, EP, BP) for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Critical for preparing impurity identification and qualification reports required for drug master files (DMFs), ANDAs, and other regulatory dossiers for health authorities like the FDA and EMA.
• Research & Synthesis: Serves as a building block or intermediate in chemical research focused on cephalosporin analogs and impurity synthesis pathways.

Basic Information

Product Name	Cefradine Impurity 8
CAS No.	150870-62-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 EP Impurity C; 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 under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.