Description

Boceprevir Metabolite M4-D9 is a deuterated, isotopically labeled analog of a key metabolite of the antiviral drug Boceprevir. This compound is of critical importance as a certified reference standard and internal standard for quantitative bioanalytical methods in drug metabolism and pharmacokinetic (DMPK) studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in the development and validation of sensitive LC-MS/MS assays for Boceprevir and its metabolites.

Application

• Primary use as a stable isotope-labeled internal standard for the precise quantification of Boceprevir Metabolite M4 in biological matrices (plasma, serum, urine) via LC-MS/MS.
• Critical component in DMPK (Drug Metabolism and Pharmacokinetics) studies to understand the metabolic fate and clearance pathways of Boceprevir.
• Essential for method development and validation in bioanalytical laboratories to ensure accuracy, precision, and regulatory compliance (FDA, EMA).
• Used as a certified reference material (CRM) for calibrating analytical instruments and verifying assay performance.
• Supports clinical trial research by enabling reliable measurement of metabolite exposure in patient samples.
• Facilitates metabolite profiling and identification studies in preclinical and clinical development stages.
• Valuable for drug-drug interaction studies where Boceprevir's metabolism may be altered by co-administered drugs.

Basic Information

Product Name	Boceprevir Metabolite M4-D9
CAS No.	1373318-84-3
Molecular Formula	C₂₇H₃₆D₉N₅O₅
Molecular Weight	Approx. 525.7 g/mol
Synonyms	(1R,2S,5S)-N-[(1S)-3-Amino-1-(cyclobutylmethyl)-2,3-dioxopropyl]-3-[(2S)-2-[[(1,1-Dimethylethyl)amino]carbonyl]amino]-3,3-dideutero-2-[(1R)-1-hydroxy-2-(methyl-d3-amino)propyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexan-2-carboxamide; (1R,2S,5S)-3-[(2S)-2-[[(1,1-Dimethylethyl)amino]carbonyl]amino]-3,3-dideutero-2-[(1R)-1-hydroxy-2-(methyl-d3-amino)propyl]-6,6-dimethyl-N-[(1S)-3-[(1,1-dimethylethoxy)carbonyl]amino-1-(cyclobutylmethyl)-2,3-dioxopropyl]-3-azabicyclo[3.1.0]hexane-2-carboxamide; Boceprevir-d9 Metabolite M4; Boceprevir Metabolite M4 Deuterated; Boceprevir M4 Isotopologue; SCH 900518 Metabolite M4-D9
EINECS	Contact for details

Quality Control

Our Boceprevir Metabolite M4-D9 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical identity required for quantitative bioanalysis. Each batch is characterized using advanced analytical techniques including NMR, HRMS, and HPLC. We provide comprehensive Certificates of Analysis (COA) detailing isotopic enrichment, chemical purity, and chromatographic data, supporting compliance with GLP (Good Laboratory Practice) and relevant regulatory guidelines for reference standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
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.