Description

Cefprozil-D4 (E/Z Mixture) is a deuterated isotopologue of the broad-spectrum cephalosporin antibiotic, Cefprozil, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and bioanalytical studies, where precise measurement is critical. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities involved in drug development and quality control.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of Cefprozil in biological matrices such as plasma, serum, and urine.
• Pharmaceutical Metabolism Studies: Used in drug metabolism and pharmacokinetics (DMPK) research to track the absorption, distribution, metabolism, and excretion (ADME) profile of Cefprozil.
• Bioanalytical Method Development & Validation: A key component in developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Enables accurate drug level monitoring in human and animal clinical trials to establish safety and efficacy profiles.
• Forensic and Anti-Doping Analysis: Supports forensic toxicology and sports anti-doping programs for the detection and confirmation of Cefprozil.
• Quality Control in Manufacturing: Can be employed in impurity profiling and stability-indicating assays during the pharmaceutical manufacturing process.

Basic Information

Product Name	Cefprozil-D4 (E/Z Mixture)
CAS No.	1426173-48-9
Molecular Formula	C18H15D4N3O5S
Molecular Weight	~ 393.44 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-(1-propen-1-yl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid-d4; Cefzil-d4; BMY-28100-d4; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid-d4 derivative; Deuterated Cefprozil; Cefprozil (phenyl-d4); Cefprozil Internal Standard
EINECS	Contact for details

Quality Control

Our Cefprozil-D4 (E/Z Mixture) is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch undergoes comprehensive testing, including HPLC for chemical purity, NMR and/or MS for structural confirmation and isotopic enrichment, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be handled under dry, inert conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 95.0%
E/Z Isomer Ratio	Specified on COA
Water Content (KF)	≤ 1.0%
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.