Description

Cefadroxil Impurity 10 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 for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cefadroxil Impurity 10 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor this specific impurity in Cefadroxil batches.
• Stability Studies and Forced Degradation: Employed to track the formation of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life and storage guidelines.
• Regulatory Submission and Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Quality Control and Batch Release Testing: Serves as a critical component in the routine QC testing of Cefadroxil to ensure every production lot meets stringent purity specifications.
• Research on Degradation Pathways: Utilized in academic and industrial research to study the chemical degradation mechanisms of Cefadroxil.

Basic Information

Product Name	Cefadroxil Impurity 10
CAS No.	2378158-44-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefadroxil Related Compound 10; Cefadroxil EP Impurity J; Cefadroxil USP Impurity; (6R,7R)-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 impurity; Cefadroxil Degradant; Cefadroxil Process Impurity
EINECS	Contact for details

Quality Control

Our Cefadroxil Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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