Description

Cefazolin Impurity 23 CAS NO 152541-04-3 is a specified impurity of the first-generation cephalosporin antibiotic, Cefazolin Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Cefazolin Sodium drug substance and finished products. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Cefazolin Impurity 23 in Cefazolin Sodium API and formulations.
• Essential for method development and validation of analytical procedures (e.g., HPLC, UPLC) in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Critical component in stability studies and impurity profiling to monitor degradation pathways and establish shelf-life for Cefazolin products.
• Used in regulatory submissions to support drug master files (DMFs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs).
• Supports quality assurance and control (QA/QC) processes to ensure batch-to-batch consistency and adherence to specified impurity limits.
• Valuable for research and development of synthetic routes and purification processes for Cefazolin Sodium.

Basic Information

Product Name	Cefazolin Impurity 23
CAS No.	152541-04-3
Molecular Formula	C14H14N8O4S3
Molecular Weight	454.51 g/mol
Synonyms	(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 Related Compound; Cefazolin EP Impurity; Cefazolin USP Impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative; Cefazolin Degradant; Cefazolin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. Certificates of Analysis (COA) with detailed chromatographic data, including retention time and system suitability, are available upon request to support your regulatory and analytical needs.

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 light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment to prevent degradation and absorption of moisture.

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 Unknown Impurity ≤ 1.0%
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.