Description

Cefazolin Impurity 32 is a characterized impurity and reference standard used in the quality control of the antibiotic Cefazolin. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams working on cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 32 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Cefazolin.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections for ANDA, NDA) by providing necessary impurity characterization data.
• Quality Control Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels are within specified limits.
• Research on Degradation Pathways: Facilitates studies to understand the chemical degradation mechanisms of Cefazolin, aiding in formulation and packaging improvements.

Basic Information

Product Name	Cefazolin Impurity 32
CAS No.	1342821-58-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Related Compound 32; Cefazolin EP Impurity 32; Cefazolin USP Impurity 32; (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; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-, (6R,7R)-; Cefazolin Impurity 32 (1342821-58-2)
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity 32 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown 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.