Description

Cefradine Ep Impurity C is a high-purity reference standard specifically identified as a process-related impurity of the antibiotic Cefradine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Cefradine-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Cefradine Ep Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Utilized in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Cefradine.

Basic Information

Item	Detail
Product Name	Cefradine Ep Impurity C
CAS No.	1147512-81-9
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; Cefradine Impurity C; Cephradine Impurity C; Cefradine Related Compound C; Cephradine EP Impurity C; Cefradine Process Impurity; Cefradine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefradine Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

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 should be handled in a dry environment to prevent degradation.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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