Description

Cefazolin Impurity 18 CAS NO 737709-74-9 is a specified impurity of the first-generation cephalosporin antibiotic, Cefazolin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is essential for quality control laboratories and manufacturers involved in the production of Cefazolin to ensure the purity, safety, and efficacy of the final drug product. This impurity standard supports compliance with stringent regulatory requirements for pharmaceutical impurities.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 18 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop and validate stability-indicating HPLC, UPLC, or LC-MS methods for Cefazolin and related substances.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Cefazolin sodium.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Cefazolin to understand degradation pathways.
• Research & Development: Utilized in pharmaceutical R&D for studying the synthesis, metabolism, and degradation chemistry of cephalosporin antibiotics.

Basic Information

Product Name	Cefazolin Impurity 18
CAS No.	737709-74-9
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 Related Compound 18; Cefazolin EP Impurity G; Cefazolin USP Related Substance 18; 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 G
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), or as indicated on the label. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants and inert atmosphere.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.