Description

Suvorexant Impurity 3 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Suvorexant. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for insomnia treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Suvorexant API and finished drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to separate, identify, and quantify impurities.
• Stability Indicating Studies: Employed to monitor the formation of degradation products in Suvorexant formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Suvorexant to ensure batches meet stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Research on Metabolic Pathways: Can be used in studies to understand the degradation pathways and stability of the Suvorexant molecule.

Basic Information

Product Name	Suvorexant Impurity 3
CAS No.	1383717-13-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Suvorexant Related Compound 3; Belsomra Impurity 3; (R)-N-((5-(4-Fluorophenyl)-2-methoxypyridin-3-yl)methyl)-2-methyl-2-(2H-1,2,3-triazol-2-yl)propanamide; Suvorexant EP Impurity C; Suvorexant USP Impurity 3; Suvorexant Process Impurity
EINECS	Contact for details

Quality Control

Our Suvorexant Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (e.g., NMR, MS), to ensure identity, potency, and consistency. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results. We support compliance with ICH guidelines and major pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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