Description

Cefazolin Impurity 9 is a specified impurity and degradation product of the first-generation cephalosporin antibiotic, Cefazolin Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection in Cefazolin Sodium.
• Stability-Indicating Studies: Employed in forced degradation studies to understand the degradation pathways and stability profile of Cefazolin formulations.
• Quality Control & Batch Release: A critical component in the quality control laboratory for routine testing to ensure batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Research on Degradation Mechanisms: Used in academic and industrial research to study the chemical behavior and formation mechanisms of this specific impurity.

Basic Information

Product Name	Cefazolin Impurity 9
CAS No.	1322626-65-2
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; 7-(1H-Tetrazol-1-ylacetamido)-3-[(5-methyl-1,3,4-thiadiazol-2-ylthio)methyl]-3-cephem-4-carboxylic Acid; Cefazolin Related Compound; Cefazolin EP Impurity; Cefazolin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 9 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment.

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) and should be kept in a dry environment. 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)	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.