Description

Daridorexant Hydrochloride is a high-purity, non-benzodiazepine dual orexin receptor antagonist (DORA) used as an active pharmaceutical ingredient (API). This compound is critical for the development and manufacturing of novel therapeutics targeting insomnia and sleep disorders by selectively inhibiting the wake-promoting orexin neuropeptides. It is primarily required by pharmaceutical R&D laboratories, formulation scientists, and contract manufacturing organizations (CMOs) engaged in central nervous system (CNS) drug production.

Application

• Pharmaceutical API: Primary use as the active ingredient in the commercial manufacture of prescription sleep medications.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in regulatory testing.
• Clinical Research: Used in preclinical and clinical trial material (CTM) production for investigating new insomnia treatments.
• Formulation Development: Essential for developing various dosage forms, such as immediate-release or film-coated tablets.
• Biochemical Research: A key tool for in vitro and in vivo studies exploring the orexin signaling pathway and its role in sleep-wake regulation.
• Generic Drug Development: Utilized by companies developing generic versions of orexin antagonist-based therapies post-patent expiry.

Basic Information

Product Name	Daridorexant Hydrochloride
CAS No.	1792993-84-0
Molecular Formula	C23H23F3N6O2 • HCl
Molecular Weight	548.93 g/mol (Hydrochloride salt)
Synonyms	Daridorexant HCl; (5)-5-[(5-Chloro-4-methyl-1H-benzimidazol-2-yl)oxy]-2-[(2R,5S)-2,5-dimethyl-1-piperazinyl]-4-(trifluoromethyl)pyrimidine Hydrochloride; ACT-541468; Nemorexant Hydrochloride; Quviviq (Trade Name) API; ID-0076; DORA API; Orexin Receptor Antagonist Hydrochloride
EINECS	Contact for details

Quality Control

Our Daridorexant Hydrochloride is manufactured under strict quality management systems. Each batch is tested to meet high-purity standards suitable for pharmaceutical applications, with comprehensive analytical profiles including HPLC purity, chiral purity, residual solvent analysis, and identification by spectroscopic methods. A Certificate of Analysis (COA) detailing all specifications and test results is provided with every shipment to ensure regulatory compliance and traceability.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5% (on anhydrous basis)
Chiral Purity (Chiral HPLC)	≥99.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Residual Solvents (GC)	Meets ICH Q3C guidelines
Related Substances (HPLC)	Total impurities ≤1.0%; Any single impurity ≤0.5%

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