Description

Cefadroxil Impurity 14 is a designated chemical reference standard used in the analysis and quality control of the antibiotic Cefadroxil. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefadroxil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), UPLC, or other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure Cefadroxil meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefadroxil.

Basic Information

Product Name	Cefadroxil Impurity 14
CAS No.	36765-61-4
Molecular Formula	C16H17N5O5S
Molecular Weight	391.40 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-α-(4-hydroxyphenyl)acetamido]-3-methyl-3-cephem-4-carboxylic Acid Impurity; Cefadroxil Related Compound; Cefadroxil EP Impurity; Cefadroxil USP Impurity; Cefadroxil Degradation Product
EINECS	Contact for details

Quality Control

Our Cefadroxil Impurity 14 is manufactured and handled under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data and traceability information.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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