Description

Cefazolin Sodium Impurity G is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Cefazolin Sodium by serving as a known impurity for method development and validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers involved in the production and analysis of cephalosporin antibiotics.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Cefazolin Sodium API and finished drug products.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for regulatory compliance (ICH Q3A, Q3B).
• Used in stability studies to monitor impurity profiles and degradation pathways of Cefazolin Sodium formulations.
• Essential for pharmacopoeial testing to meet standards set by USP, EP, BP, and other international pharmacopoeias.
• Supports research and development of new analytical techniques and impurity characterization studies.
• Used in quality assurance/quality control (QA/QC) processes to ensure batch-to-batch consistency and product safety.

Basic Information

Product Name	Cefazolin Sodium Impurity G
CAS No.	1172998-53-6
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 Impurity G; Cefazolin Related Compound G; Cefazolin EP Impurity G; Cefazolin USP Impurity G; 1H-Tetrazole-1-acetic acid, 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid derivative
EINECS	Contact for details

Quality Control

Our Cefazolin Sodium Impurity G is manufactured under strict quality systems to ensure it meets the stringent requirements for use as a reference standard. Each batch is subjected to comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results and confirming compliance with in-house specifications aligned with pharmacopoeial expectations.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.