Description

Cefuroxime Impurity 7 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Cefuroxime. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of related substances during drug development and manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on ensuring the purity, safety, and regulatory compliance of Cefuroxime-based pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of Cefuroxime.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity identity and characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of degradation products in Cefuroxime formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and in the development of purification processes.

Basic Information

Product Name	Cefuroxime Impurity 7
CAS No.	37051-07-3
Molecular Formula	C16H16N4O8S
Molecular Weight	424.39 g/mol
Synonyms	(6R,7R)-3-[(Carbamoyloxy)methyl]-7-[[(2Z)-2-(2-furyl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 7β-[2-(2-Furyl)-2-(Methoxyimino)acetamido]-3-(carbamoyloxymethyl)-3-cephem-4-carboxylic Acid; Cefuroxime Related Compound B; Cefuroxime Impurity B; (6R,7R)-7-[2-(Furan-2-yl)-2-(methoxyimino)acetamido]-3-[(aminocarbonyloxy)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Cefuroxime Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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