Description

Ethambutol-D8 is a deuterated analog of the first-line antitubercular agent Ethambutol, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity, isotopically labeled compound is essential for ensuring the accuracy and reliability of mass spectrometry-based assays, eliminating matrix effects and improving data precision. It is a critical material for pharmaceutical research and development laboratories, clinical testing facilities, and regulatory bodies focused on drug metabolism studies, pharmacokinetic analysis, and therapeutic drug monitoring for tuberculosis treatment.

Application

• Primary use as an Internal Standard for the accurate quantification of Ethambutol in biological matrices (plasma, serum, urine) via LC-MS/MS and GC-MS.
• Essential component in Drug Metabolism and Pharmacokinetics (DMPK) studies to track the absorption, distribution, metabolism, and excretion of Ethambutol.
• Critical for Bioanalytical Method Development and Validation in compliance with FDA, EMA, and ICH guidelines.
• Used in Therapeutic Drug Monitoring (TDM) assays to optimize dosing regimens and ensure effective tuberculosis treatment.
• Supports Pharmaceutical Impurity Profiling and stability-indicating method development for Ethambutol-based drug products.
• Valuable reference material in Clinical Research and trials involving antimycobacterial therapies.

Basic Information

Item	Detail
Product Name	Ethambutol-D8
CAS No.	1129526-23-3
Molecular Formula	C10H16D8N2O2
Molecular Weight	208.33 g/mol
Synonyms	(2S,2'S)-2,2'-(Ethane-1,2-diyldiimino)dibutan-1-ol-d8; (+)-N,N'-Bis(1-hydroxymethylpropyl)ethylenediamine-d8; EMB-D8; (S,S)-Ethambutol-D8; Dexambutol-D8; Myambutol-D8; Etibi-D8; Deuterated Ethambutol Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Ethambutol-D8 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, MS, and HPLC. A Certificate of Analysis (COA) detailing purity, isotopic enrichment, and solvent content is provided with each shipment. Our quality commitment ensures the material meets the stringent requirements for regulatory bioanalysis and research.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 0.5%

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