Description

Cefuroxime Impurity 33 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 Cefuroxime by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on analytical development and pharmacopeial compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cefuroxime Impurity 33 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and separation.
• Quality Control & Stability Studies: Employed in routine batch testing and forced degradation studies to monitor impurity levels and ensure product stability over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research on Degradation Pathways: Aids in research to understand the formation pathways and chemical behavior of this specific impurity during synthesis and storage.

Basic Information

Product Name	Cefuroxime Impurity 33
CAS No.	929531-94-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-3-[(Acetyloxy)methyl]-7-[[(2Z)-2-(2-furanyl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefuroxime Related Compound; Cefuroxime EP Impurity; Cefuroxime USP Impurity; Cefuroxime Acid Impurity
EINECS	Contact for details

Quality Control

Our Cefuroxime Impurity 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and chromatographic data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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