Description

Risperidone (Mesylate) CAS NO 666179-96-0 is a mesylate salt form of the atypical antipsychotic drug risperidone. This salt formation enhances the compound's stability and handling characteristics, making it a critical intermediate in the synthesis of high-purity active pharmaceutical ingredients (APIs). It is essential for pharmaceutical manufacturers and research organizations requiring a reliable, high-quality starting material for the production of antipsychotic medications. This product is supplied to meet the stringent demands of the global pharmaceutical and fine chemical industries.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary use as a key intermediate in the commercial-scale manufacturing of risperidone and its final dosage forms.
• Pharmaceutical Research & Development: Serves as a critical reference standard and starting material in preclinical and clinical studies for novel antipsychotic formulations.
• Generic Drug Production: Essential for manufacturers producing generic versions of risperidone-based medications, ensuring bioequivalence and regulatory compliance.
• Process Chemistry & Optimization: Used in the development and scaling of efficient, cost-effective synthetic routes for antipsychotic APIs.
• Analytical Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods to assay drug products.
• Contract Manufacturing (CMO): Supplied to contract development and manufacturing organizations (CDMOs) specializing in potent and psychotropic substances.

Basic Information

Product Name	Risperidone (Mesylate)
CAS No.	666179-96-0
Molecular Formula	C23H27FN4O2 • CH4O3S
Molecular Weight	494.59 g/mol
Synonyms	Risperidone Mesylate; Risperidone Methanesulfonate; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one methanesulfonate; Risperidone Mesylate Salt; Risperidone Monomesylate; Risperdal Mesylate (related to trade name)
EINECS	Contact for details

Quality Control

Our Risperidone (Mesylate) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide full traceability and detailed Certificates of Analysis (COA) with each shipment, which include data for identity, purity, and impurity profiles. Our quality commitment aligns with cGMP principles to support our clients' regulatory submissions and production needs.

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 in a dry environment to prevent degradation. For long-term storage, consider using desiccants or inert atmosphere packaging.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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