Description

Cefazolin Impurity 7/Cefazolin Ep Impurity J/2-((2-(1H-Tetrazol-1-Yl)Acetamido)(Carboxy)Methyl)-5-Methylene-5,6-Dihydro-2H-1,3-Thiazine-4-Carboxylic Acid is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity for the quality control and validation of analytical methods for the antibiotic Cefazolin. It is essential for pharmaceutical manufacturers and analytical laboratories focused on ensuring drug safety, efficacy, and regulatory compliance. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial standards (USP/EP) in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cefazolin Impurity 7 in Cefazolin Sodium API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, calibrating, and validating chromatographic methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Cefazolin drug substances and products meet specified purity limits and regulatory requirements.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Supports investigative studies to understand the formation mechanisms and chemical behavior of this impurity during synthesis and storage.

Basic Information

Product Name	Cefazolin Impurity 7 / Cefazolin EP Impurity J
CAS No.	1675245-00-7
Molecular Formula	C14H15N7O6S
Molecular Weight	409.38 g/mol
Synonyms	2-((2-(1H-Tetrazol-1-yl)acetamido)(carboxy)methyl)-5-methylene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid; Cefazolin Impurity J (EP); Cefazolin Related Compound J; (6R,7R)-7-[[(2-(1H-Tetrazol-1-yl)acetyl)amino]](carboxymethyl)-8-oxo-3-[(1,3,4-thiadiazol-2-ylthio)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid impurity; Cefazolin Degradant; Cefazolin Sodium Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing batch-specific results, analytical methods, and traceability. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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% w/w
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.