Description

Cefepime Impurity 13 is a specified, structurally characterized impurity used in the quality control and regulatory compliance of the fourth-generation cephalosporin antibiotic, Cefepime. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and adherence to strict pharmacopeial standards. It is primarily utilized in research and development, method validation, and as a certified reference material for impurity profiling and quantification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cefepime Impurity 13 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Cefepime.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Cefepime API and formulations meet ICH Q3A/B guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification, characterization, and control strategies.
• Research on Degradation Pathways: Used in research to study the chemical degradation mechanisms of Cefepime, aiding in the development of more stable formulations.

Basic Information

Product Name	Cefepime Impurity 13
CAS No.	112533-07-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Cefepime Related Compound; Cefepime EP Impurity C; Cefepime USP Related Compound; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium; Cefepime Impurity (EP).
EINECS	Contact for details

Quality Control

Our Cefepime Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, assay, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product 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
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.