Description

(R,S)-Palonosetron Hydrochloride CAS NO 135755-51-0 is a high-purity pharmaceutical intermediate and reference standard, chemically known as a 5-HT₃ receptor antagonist. This compound is critical for ensuring the quality, safety, and efficacy of antiemetic drug development and manufacturing processes. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in the synthesis, quality control, and regulatory submission of palonosetron-based therapeutics.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a key chiral intermediate in the production of the antiemetic drug Palonosetron.
• Pharmaceutical Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing of drug substances and finished products.
• Research and Development: Employed in preclinical and clinical studies to investigate the pharmacology and metabolism of 5-HT₃ receptor antagonists.
• Impurity Profiling: Acts as a critical system suitability standard or impurity marker in HPLC and LC-MS analyses to ensure drug purity.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing a characterized material for stability studies and specification setting.
• Process Chemistry Optimization: Used to develop and scale up efficient, GMP-compliant synthetic routes for palonosetron hydrochloride.

Basic Information

Product Name	(R,S)-Palonosetron Hydrochloride
CAS No.	135755-51-0
Molecular Formula	C19H24N2O • HCl
Molecular Weight	332.87 g/mol (Free base: 296.41)
Synonyms	Palonosetron HCl (racemic); (±)-Palonosetron Hydrochloride; (RS)-Palonosetron Hydrochloride; 2-[(3aS)-2-[(1R,4r,7S)-7-Azabicyclo[2.2.1]heptan-2-yl]-2,3,3a,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one] Hydrochloride; Aloxi Intermediate; ONO-4578 (racemate); BRS-Palonosetron HCl; NSC 726281 (Hydrochloride)
EINECS	Contact for details

Quality Control

Our (R,S)-Palonosetron Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and composition. Certificates of Analysis (COA) are provided, detailing results from advanced techniques like HPLC, NMR, and mass spectrometry. We support compliance with ICH guidelines, USP standards, and customer-specific requirements for pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%
Optical Rotation (for chiral purity)	Contact for details

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