Description

Cefuroxime Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Cefuroxime. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and regulatory compliance testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Cefuroxime Impurity 11 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods used in quality control laboratories.
• Stability Studies: Used to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Cefuroxime.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity profiles and demonstrating comprehensive quality control measures.
• Pharmaceutical Research: Aids in research focused on understanding the degradation pathways and impurity formation mechanisms of cephalosporin antibiotics.
• Quality Assurance/Quality Control (QA/QC): Employed as a system suitability standard and for routine batch release testing to ensure impurity levels are within specified limits.

Basic Information

Product Name	Cefuroxime Impurity 11
CAS No.	929531-97-5
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; Cefuroxime Related Compound; Cefuroxime Impurity; Cefuroxime EP Impurity; Cefuroxime USP Impurity; Cefuroxime Degradation Product; (6R,7R)-7-[(Z)-2-(2-Furyl)-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

Our Cefuroxime Impurity 11 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical impurity standards. Certificates of Analysis (COA) are provided, detailing results from comprehensive tests including HPLC purity, identification (IR, NMR), and residual solvent analysis. We support compliance with major pharmacopoeial standards (USP, EP, BP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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