Description

Cefazolin Impurity 17 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 drug substances and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards such as USP, EP, and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefazolin Sodium API and formulations.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, primarily using HPLC and UPLC techniques.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Cefazolin products.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) guidelines.
• Regulatory Submissions: Critical for compiling impurity data in regulatory filings (e.g., ANDA, NDA, CEP) to demonstrate product understanding and control strategy.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Cefazolin to improve formulation stability.

Basic Information

Product Name	Cefazolin Impurity 17
CAS No.	38509-92-1
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; 3-[(5-Methyl-1,3,4-thiadiazol-2-ylthio)methyl]-7-[2-(1H-tetrazol-1-yl)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefazolin Related Compound B (EP); Cefazolin Impurity B
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

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 must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.