Description

Cefuroxime Sodium Ep Impurity C is a high-purity reference standard used for the analytical profiling and quality control of the antibiotic Cefuroxime Sodium. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial monographs. It is primarily utilized in research, method development, and as a certified impurity standard in the production and quality assurance of Cefuroxime Sodium active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for identification and quantification in Cefuroxime Sodium API and finished product testing.
• Quality Control & Assurance (QC/QA): Essential for HPLC, UPLC, and other chromatographic methods to monitor and control impurity levels during API synthesis and formulation.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing validated data for impurity profiles as required by ICH guidelines.
• Method Development & Validation: Used in developing and validating analytical methods for stability studies and release testing of Cefuroxime Sodium products.
• Research & Development (R&D): Employed in studies to understand degradation pathways and to synthesize and characterize related substances.

Basic Information

Product Name	Cefuroxime Sodium Ep Impurity C
CAS No.	69822-88-4
Molecular Formula	C16H15N4O8S2Na
Molecular Weight	478.43 g/mol
Synonyms	(6R,7R)-3-[(Carbamoyloxy)methyl]-7-[[(Z)-2-(furan-2-yl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Sodium Salt; Cefuroxime Sodium Impurity C; Cefuroxime EP Impurity C; Cefuroxime Sodium Related Compound C; Sodium (6R,7R)-3-[(aminocarbonyl)oxy]methyl]-7-[(Z)-2-(2-furyl)-2-(methoxyimino)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Cefuroxime Sodium Ep Impurity C is manufactured and analyzed under strict quality management systems. The product is characterized and qualified using advanced analytical techniques including HPLC, MS, and NMR to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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