Description

Cefadroxil Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of impurities in Cefadroxil drug substances and finished products. It is an essential material for analytical laboratories in the pharmaceutical industry, regulatory bodies, and research institutions focused on method development and validation to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Cefadroxil.
• Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and finished dosage form producers to monitor batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and dossiers.
• Stability Studies: Employed to track the formation of degradation products in Cefadroxil under various stress conditions.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and chemical behavior of cephalosporin antibiotics.

Basic Information

Product Name	Cefadroxil Impurity 8
CAS No.	2243976-70-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefadroxil Related Compound 8; Cefadroxil EP Impurity 8; Cefadroxil USP Impurity 8; Cefadroxil Degradation Product; (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 Process Impurity; Cefadroxil Specified Impurity
EINECS	Contact for details

Quality Control

Our Cefadroxil Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC and LC-MS. We support compliance with major pharmacopoeial standards (USP, EP, BP) and ICH Q3A/B 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 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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.