Description

Cefepime-D3 Sulfate is a deuterium-labeled internal standard of the fourth-generation cephalosporin antibiotic, cefepime. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative mass spectrometry analyses in pharmaceutical research and quality control. It is primarily used by analytical laboratories, pharmaceutical R&D departments, and contract research organizations (CROs) engaged in pharmacokinetic studies, bioanalytical method development, and drug metabolism research.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the precise quantification of cefepime in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME) parameters.
• Method Development and Validation: Essential for developing and validating robust, regulatory-compliant analytical methods for cefepime in accordance with ICH, FDA, and EMA guidelines.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of cefepime.
• Quality Control & Stability Testing: Supports impurity profiling and assay development for cefepime drug substance and finished pharmaceutical products.
• Clinical Trial Support: Provides reliable data for bioequivalence and therapeutic drug monitoring (TDM) studies during clinical development phases.

Basic Information

Product Name	Cefepime-D3 Sulfate
CAS No.	131857-28-8
Molecular Formula	C19H21D3N6O5S2 • H2SO4
Molecular Weight	Approx. 612.66 g/mol
Synonyms	1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium-d3 sulfate; (6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetamido]-3-(1-methyl-1-d3-pyrrolidinio)methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sulfate; Cefepime-d3 sulfate salt; Deuterated Cefepime Sulfate
EINECS	Contact for details

Quality Control

Our Cefepime-D3 Sulfate is manufactured under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, isotopic enrichment (≥98 atom % D), and chemical purity (typically ≥95%). Certificates of Analysis (COA) detailing batch-specific results are provided to support your regulatory submissions and ensure traceability and compliance with GLP/GMP principles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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