Description

Atogepant (Mk-8031) is a potent, orally administered small molecule calcitonin gene-related peptide (CGRP) receptor antagonist. This compound is of significant interest for its targeted mechanism of action in the prevention of chronic and episodic migraine. It is a critical pharmaceutical intermediate and active pharmaceutical ingredient (API) for research, development, and commercial manufacturing within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of prescription migraine preventive medications.
• Clinical & Pre-clinical Research: Serves as a reference standard and key material for pharmacological studies and drug development programs.
• Process Development & Scale-up: Used in optimizing synthetic routes and manufacturing processes for commercial production.
• Analytical Method Development: Employed as a high-purity standard for establishing and validating HPLC, LC-MS, and other analytical techniques.
• Regulatory Submissions: Supplied as a qualified material for inclusion in regulatory filings (e.g., IND, NDA, MAA) to health authorities worldwide.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.

Basic Information

Product Name	Atogepant (Mk-8031)
CAS No.	1374248-81-3
Molecular Formula	C29H30F2N6O3
Molecular Weight	548.58 g/mol
Synonyms	MK-8031; AGN-241689; (2S)-N-[(3S,5S,6R)-6-Methyl-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-5-azaspiro[2.4]heptan-7-yl]-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide; Atogepant free base
EINECS	Contact for details

Quality Control

Our Atogepant (Mk-8031) is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength. We provide full traceability and support regulatory requirements with comprehensive documentation, including detailed Certificates of Analysis (COA). Specifications are aligned with ICH guidelines and current Good Manufacturing Practice (cGMP) standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccated environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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