Description

Cefazedone Related 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 Cefazedone by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams focused on method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for identifying and quantifying this specific impurity in Cefazedone active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Stability Studies and Forced Degradation Testing: Employed to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Synthesis Pathway Investigation: Used by chemists to study the synthesis and degradation pathways of Cefazedone, aiding in process optimization and impurity minimization.

Basic Information

Product Name	Cefazedone Related Impurity 10
CAS No.	18884-65-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-ACA Impurity; Cefazedone Impurity; Cefazedone Process Impurity; Cefazedone Related Compound; (6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (related isomer); Cephalosporin Impurity; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Our Cefazedone Related Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.