Description

Cefuroxime Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in Cefuroxime drug substances and finished products. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical development and manufacturing, ensuring compliance with stringent regulatory standards for drug purity and safety.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualification and calibration of analytical instruments (HPLC, LC-MS).
• Impurity Profiling & Method Development: Critical for developing and validating analytical methods to detect and quantify impurities in Cefuroxime batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing of active pharmaceutical ingredients (APIs) to ensure they meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and track degradation products formed during drug product stability testing under various conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity identification data for health authorities like the FDA and EMA.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing impurity formation during Cefuroxime synthesis.

Basic Information

Product Name	Cefuroxime Impurity 9
CAS No.	2165460-37-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-3-[(Acetyloxy)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 Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefuroxime Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual Impurity: ≤ 1.0% Total Impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Guidelines

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