Description

Cefazolin Ep Impurity K is a specified impurity used in the quality control and analytical profiling of the antibiotic Cefazolin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Cefazolin drug substances and products in compliance with stringent pharmacopeial standards. It is an essential reference standard for research, method development, and regulatory submissions within the global pharmaceutical industry.

Application

• Primary use as a pharmacopeial reference standard (EP/JP/USP) for Cefazolin quality control.
• Critical component in analytical method development and validation (HPLC, LC-MS) for impurity profiling.
• Used in stability studies and forced degradation testing of Cefazolin formulations.
• Essential for regulatory compliance and submission to agencies like the FDA and EMA.
• Serves as a high-purity calibrant in quantitative impurity analysis.
• Supports research and development of Cefazolin synthesis and purification processes.
• Utilized by contract research organizations (CROs) and quality control laboratories.

Basic Information

Product Name	Cefazolin Ep Impurity K
CAS No.	1391053-58-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Impurity K; Cefazolin Related Compound K; (6R,7R)-3-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefazolin EP Impurity K; Cefazolin USP Impurity K; Cefazolin Degradant; Cefazolin Process Impurity
EINECS	Contact for details

Quality Control

Our Cefazolin Ep Impurity K is manufactured under strict quality systems to ensure it meets the exacting standards required for use as a reference material. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, documenting batch-specific results and traceability. Our quality commitment supports compliance with cGMP and relevant ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Specific Rotation	Contact for details

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