Description

Suvorexant Impurity 2 CAS NO 1276666-19-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the insomnia drug Suvorexant. It is primarily required by analytical laboratories and pharmaceutical companies for method validation, impurity profiling, and ensuring batch-to-batch consistency and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Suvorexant active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis.
• Quality Assurance & Control (QA/QC): Serves as a system suitability standard and for routine testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradant under various stress conditions (light, heat, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to define impurity limits and justify the control strategy.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for the main API.

Basic Information

Product Name	Suvorexant Impurity 2
CAS No.	1276666-19-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5R)-5-[(5-Chloro-1,3-benzoxazol-2-yl)oxymethyl]-4-methyl-1,4-oxazepane; Suvorexant Related Compound 2; Belsomra Impurity 2; MK-4305 Impurity 2; Suvorexant Degradant; Suvorexant Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Suvorexant Impurity 2 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic profiles is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.