Description

Boceprevir Metabolite M4-D9 Methyl Ester is a high-purity, stable isotope-labeled compound primarily used as a critical reference standard in pharmaceutical research and development. This deuterated metabolite is essential for accurate quantification and metabolic pathway studies, ensuring data integrity in complex analytical workflows. It is indispensable for laboratories in the pharmaceutical, contract research organization (CRO), and academic sectors focused on antiviral drug metabolism, pharmacokinetics (PK), and bioanalytical method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of Boceprevir and its metabolites in biological matrices using LC-MS/MS and HPLC methods.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in in vitro and in vivo studies to elucidate the metabolic fate, clearance pathways, and bioavailability of Boceprevir.
• Bioanalytical Method Development & Validation: Critical for developing, optimizing, and validating robust, GLP-compliant analytical methods for clinical and preclinical trials.
• Isotope Dilution Mass Spectrometry (IDMS): Enables highly accurate and sensitive measurements by correcting for analyte loss and matrix effects during sample preparation and analysis.
• Metabolite Identification and Profiling: Aids in the structural confirmation and profiling of Boceprevir metabolites to assess drug safety and efficacy.
• Quality Control in API Manufacturing: Supports impurity profiling and quality control processes during the active pharmaceutical ingredient (API) manufacturing of antiviral drugs.

Basic Information

Product Name	Boceprevir Metabolite M4-D9 Methyl Ester
CAS No.	1158083-48-7
Molecular Formula	C27H36D9N5O5
Molecular Weight	Contact for details
Synonyms	(1R,2S,5S)-N-[(1S)-3,3-Dimethyl-1-[(2S)-2-[[(1R,2S,5S)-3-[(2S)-2-[(Methoxycarbonyl)amino]-3,3-dimethylbutanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexan-2-yl]carbamoyl]pyrrolidin-1-yl]-1-oxobutan-2-yl]-3-[(2S)-2-[(Methoxy-d3)carbonyl-d3]amino-3,3-dimethyl-d6-butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide; Boceprevir Metabolite M4 Methyl-d9 Ester; Deuterated Boceprevir Metabolite M4 Methyl Ester; M4-D9 Methyl Ester; SCH 900518 Metabolite M4-D9 Methyl Ester
EINECS	Contact for details

Quality Control

Every batch of Boceprevir Metabolite M4-D9 Methyl Ester is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, verified by advanced spectroscopic and chromatographic techniques including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, isotopic enrichment, and analytical results. Our quality commitment supports compliance with standards relevant to reference material production.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity. For long-term storage, consider storing at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95%
Isotopic Purity (D-content)	≥ 98 atom % D
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.