Description

Ertapenem-D4 Disodium is a deuterated isotopologue of the carbapenem antibiotic ertapenem, specifically labeled with four deuterium atoms. This compound is a critical internal standard used in quantitative mass spectrometry to ensure accurate pharmacokinetic and bioanalytical measurements. It is essential for pharmaceutical R&D, clinical research, and quality control laboratories requiring high-fidelity analytical data. The product is supplied as the disodium salt, enhancing its solubility and stability for precise laboratory use.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise LC-MS/MS quantification of ertapenem in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Method Development and Validation: Used to develop, optimize, and validate robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Drug Metabolism Research: Facilitates studies on the metabolic pathways and stability of ertapenem without isotopic interference.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification during the production of ertapenem API and finished dosage forms.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring and efficacy studies in human trials.

Basic Information

Product Name	Ertapenem-D4 Disodium
CAS No.	1356934-56-9
Molecular Formula	C22H21D4N3Na2O7S
Molecular Weight	497.48 g/mol (anhydrous basis)
Synonyms	Ertapenem-d4 Disodium Salt; (4R,5S,6S)-3-[[(3S,5S)-5-[[(3-Carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid-d4 Disodium Salt; (-)-(4R,5S,6S)-3-[[(3S,5S)-5-[[(3-Carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid-d4 Disodium; INVANZ Impurity D4 (Disodium Salt); Deuterated Ertapenem Disodium
EINECS	Contact for details

Quality Control

Our Ertapenem-D4 Disodium is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including NMR and mass spectrometry to confirm isotopic enrichment and chemical purity, and HPLC for assay and impurity profiling. We provide comprehensive Certificates of Analysis (COA) detailing purity, isotopic purity, and residual solvent levels, supporting traceability and regulatory compliance for research and development.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity	≥ 90.0% (by NMR)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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