Description

Cefazolin-13C2-15N CAS NO 2101505-58-0 is a high-purity, stable isotope-labeled analog of the first-generation cephalosporin antibiotic, Cefazolin. This compound is an essential internal standard and reference material for the precise quantification and pharmacokinetic studies of Cefazolin in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in drug metabolism, bioanalytical method development, and clinical research to ensure data accuracy and regulatory compliance.

Application

• Bioanalytical Method Development & Validation: Serves as a critical internal standard for the accurate and reliable quantification of Cefazolin in plasma, serum, urine, and tissue samples via LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Metabolite Identification & Profiling: Used as a reference standard to identify and characterize Cefazolin metabolites in biological systems.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Supports the development of robust assays for monitoring Cefazolin concentrations in patients to optimize dosing regimens.
• Quality Control in Pharmaceutical Manufacturing: Acts as a certified reference material for in-process testing and final product release of Cefazolin-based pharmaceuticals.
• Regulatory Submissions: Provides essential data traceability and method robustness required for FDA, EMA, and other global regulatory agency filings.

Basic Information

Product Name	Cefazolin-13C2-15N
CAS No.	2101505-58-0
Molecular Formula	C13H14N8O4S3 (with 13C and 15N isotopes specified)
Molecular Weight	Contact for details
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-13C2-15N; Cefazolin-13C2,15N; Cefamezin-13C2-15N; Ancef-13C2-15N; Kefzol-13C2-15N; 13C2,15N-Labeled Cefazolin; Isotopically Labeled Cefazolin; Cefazolin Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Cefazolin-13C2-15N is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and isotopic enrichment verification using advanced techniques including NMR (1H, 13C), High-Resolution Mass Spectrometry (HRMS), and HPLC to ensure compliance with the highest standards for reference materials. Certificates of Analysis (COA) detailing batch-specific results for isotopic purity, chemical purity, and residual solvents are provided and traceable to in-house reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (NMR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C)	≥ 99 atom % 13C
Isotopic Purity (15N)	≥ 99 atom % 15N
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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