Description

Cefadroxil Ep Impurity C is a specified impurity used in the quality control and analytical profiling of the antibiotic Cefadroxil. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug substance in compliance with stringent pharmacopeial standards. It is primarily utilized in research, method development, and as a certified reference material for HPLC and other chromatographic analyses.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cefadroxil Ep Impurity C in Cefadroxil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and CMC (Chemistry, Manufacturing, and Controls) sections.
• Stability Studies: Used to monitor impurity profiles during forced degradation and long-term stability studies of Cefadroxil.
• Pharmaceutical R&D: Employed in research to understand the degradation pathways and synthesis impurities of Cefadroxil.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch release testing to ensure Cefadroxil API meets the specifications of pharmacopeias like EP (European Pharmacopoeia) and USP.

Basic Information

Product Name	Cefadroxil Ep Impurity C
CAS No.	147103-96-6
Molecular Formula	C16H17N3O5S
Molecular Weight	363.39 g/mol
Synonyms	(6R,7R)-7-[[(2R)-Amino(4-hydroxyphenyl)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(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, (6R,7R)-; Cefadroxil Impurity C (EP); Cefadroxil Related Compound C; Cefadroxil EP Impurity C
EINECS	Contact for details

Quality Control

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

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 under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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