Description

Rolapitant Hydrochloride (Anhydrous) is a high-purity, non-hydrated salt form of the selective neurokinin-1 (NK1) receptor antagonist. This compound is of significant commercial and research interest for its potent antiemetic properties, specifically targeting the delayed phase of chemotherapy-induced nausea and vomiting (CINV). It is primarily utilized by pharmaceutical manufacturers and advanced research institutions engaged in oncology supportive care and central nervous system (CNS) drug development. The anhydrous grade ensures optimal stability and consistency for formulation and analytical purposes.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of antiemetic medications.
• Oncology Supportive Care: Key component in formulations designed to prevent delayed CINV.
• Pharmaceutical R&D: Used in preclinical and clinical studies for new therapeutic agents targeting the NK1 pathway.
• Reference Standard: Serves as a high-purity calibrant in analytical laboratories for quality control and method development.
• Process Chemistry: Intermediate or starting material for the synthesis of novel chemical entities in medicinal chemistry.
• Formulation Development: Employed in stability studies and the development of various dosage forms, including tablets and injectables.

Basic Information

Product Name	Rolapitant Hydrochloride (Anhydrous)
CAS No.	858102-79-1
Molecular Formula	C31H34F2N4O2 • HCl
Molecular Weight	577.09 g/mol
Synonyms	Rolapitant HCl; Rolapitant Monohydrochloride; (5S,8S)-8-{[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy}methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one Hydrochloride; Varubi (Brand Name); SCH 619734; Rolapitant Hydrochloride Anhydrous
EINECS	Contact for details

Quality Control

Our Rolapitant Hydrochloride (Anhydrous) is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Rotation	Contact for details

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