Description

Cefuroxime Sodium Ep Impurity G is a high-purity chemical reference standard, specifically identified as an impurity of the antibiotic Cefuroxime Sodium. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefuroxime Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity profiles and establishing specification limits as per ICH guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Cefuroxime Sodium formulations.
• Pharmacopoeial Testing: Used in testing to comply with monographs in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international pharmacopoeias.
• Research & Development: Serves as a key material in R&D for studying the degradation pathways and chemical behavior of Cefuroxime Sodium.

Basic Information

Product Name	Cefuroxime Sodium Ep Impurity G
CAS No.	97232-98-9
Molecular Formula	C16H15N4O8S2Na
Molecular Weight	478.43 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-carboxylate Sodium Salt; Sodium (6R,7R)-3-[(aminocarbonyl)oxy]methyl]-7-[[(2Z)-2-(2-furanyl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Cefuroxime Impurity G (Sodium Salt); Cefuroxime Sodium Related Compound G; Cefuroxime EP Impurity G Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of Cefuroxime Sodium Ep Impurity G is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmacopoeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, NMR, MS) is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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