Description

Cefadroxil Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Cefadroxil during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The material is essential for method development, validation, and the accurate quantification of impurities in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cefadroxil Impurity 6 in drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA/ANDA).
• Stability Studies: Used as a marker to track impurity formation in Cefadroxil under various stress and long-term storage conditions.
• Research & Development: Facilitates studies on the degradation pathways, synthesis, and toxicological profile of Cefadroxil-related substances.

Basic Information

Product Name	Cefadroxil Impurity 6
CAS No.	2378158-45-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5R,6R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefadroxil Related Compound; Cefadroxil EP Impurity; Cefadroxil USP Impurity; Cefadroxil Degradant; Cefadroxil Process Impurity; Cefadroxil Desacetyl Impurity
EINECS	Contact for details

Quality Control

Our Cefadroxil Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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