Description

Cefadroxil Related Compound I is a high-purity chemical reference standard, essential for the accurate analysis and quality control of the antibiotic Cefadroxil. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, regulatory compliance, and batch-to-batch consistency. It is primarily used in research and development, method validation, and as a critical impurity standard in the production of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cefadroxil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Quality Control & Assurance: Serves as a system suitability component and a known impurity marker to monitor the stability and purity of Cefadroxil throughout its shelf life.
• Regulatory Compliance & Documentation: Supports compliance with stringent pharmacopoeial standards (USP, EP, BP) and regulatory submissions (FDA, EMA) by providing traceable impurity data.
• Research & Development: Utilized in studies investigating the degradation pathways, stability profile, and synthesis impurities of cephalosporin antibiotics.

Basic Information

Product Name	Cefadroxil Related Compound I
CAS No.	147103-94-4
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; 7-[D-(-)-α-Amino-p-hydroxybenzamido]-3-methyl-3-cephem-4-carboxylic Acid; Cefadroxil Impurity I; Cefadroxil EP Impurity I; Cefadroxil Related Substance I
EINECS	Contact for details

Quality Control

Our Cefadroxil Related Compound I is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Assay	95.0% - 105.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
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.