Description

Boceprevir Metabolite M15 is a key intermediate and reference standard used in pharmaceutical research and development. This compound is critical for studying the metabolic pathways, pharmacokinetics, and safety profiles of the antiviral drug Boceprevir. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the qualitative and quantitative analysis of Boceprevir and its related substances in drug substances and products.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo studies to identify, characterize, and quantify metabolic products during drug development.
• Bioanalytical Method Development: Used as a critical reagent for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for biological samples.
• DMPK Studies: Employed in drug metabolism and pharmacokinetics research to understand absorption, distribution, metabolism, and excretion (ADME) properties.
• Impurity Synthesis & Control: Acts as a starting material or intermediate for synthesizing specified impurities and degradation products required for regulatory filings.
• Toxicology & Safety Assessment: Used in studies to assess the potential toxicity and safety of drug metabolites.

Basic Information

Product Name	Boceprevir Metabolite M15
CAS No.	1351791-45-1
Molecular Formula	C27H45N5O5
Molecular Weight	519.68 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-dimethyl-1-oxobutyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexan-2-carboxamide; (1R,2S,5S)-3-[(2S)-2-[(tert-Butylcarbamoyl)amino]-3,3-dimethylbutanoyl]-N-[(1S)-1-(cyclobutylmethyl)-2,3-dioxo-3-aminopropyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide; Boceprevir Carboxylic Acid Metabolite; Boceprevir M15; SCH 900518 Metabolite M15.
EINECS	Contact for details

Quality Control

Our Boceprevir Metabolite M15 is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for research and development. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by advanced chromatographic methods like HPLC and LC-MS. We support compliance with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at -20°C under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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