Description

Cefuroxime Sodium Ep Impurity F is a high-purity chemical reference standard, specifically identified as an impurity of the antibiotic Cefuroxime Sodium. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies to ensure the purity, safety, and efficacy of Cefuroxime Sodium drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cefuroxime Sodium Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or other chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure drug substance and drug product batches comply with stringent pharmacopeial limits for specified impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and shelf-life studies.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA, PMDA) by providing characterized impurity material for qualification and toxicological assessment.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Cefuroxime Sodium, helping to improve formulation stability.

Basic Information

Product Name	Cefuroxime Sodium Ep Impurity F
CAS No.	97170-19-9
Molecular Formula	C16H15N4O8S2Na
Molecular Weight	478.43 g/mol
Synonyms	(6R,7R)-3-[(Carbamoyloxy)methyl]-7-[[(2Z)-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 Impurity F (EP); Cefuroxime Sodium Impurity F; Cefuroxime Related Compound F; Sodium (6R,7R)-3-[(aminocarbonyl)oxy]methyl]-7-[(2Z)-2-(2-furanyl)-2-(methoxyimino)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; 97170-19-9
EINECS	Contact for details

Quality Control

Our Cefuroxime Sodium Ep Impurity F is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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