Description

Risperidone (Hydrochloride) CAS NO 666179-74-4 is a high-purity active pharmaceutical ingredient (API) and a key intermediate in the synthesis of the antipsychotic medication risperidone. Its primary value lies in providing a reliable and well-characterized salt form for pharmaceutical development and manufacturing, ensuring consistent quality and performance in final drug formulations. This compound is essential for pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of neuropsychiatric therapeutics.

Application

• Pharmaceutical API Synthesis: Primary raw material for the commercial production of the antipsychotic drug Risperidone.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development, validation, and quality control testing.
• Research & Development: Critical intermediate in medicinal chemistry research for developing new central nervous system (CNS) active compounds and studying structure-activity relationships (SAR).
• Formulation Development: Employed in pre-formulation and formulation studies to develop various dosage forms such as tablets, orally disintegrating tablets (ODTs), and long-acting injectables.
• Generic Drug Manufacturing: Serves as a key starting material (KSM) or intermediate for manufacturers producing generic versions of risperidone.
• Process Chemistry: Used in scaling up and optimizing synthetic routes for risperidone production under current Good Manufacturing Practices (cGMP).

Basic Information

Item	Detail
Product Name	Risperidone (Hydrochloride)
CAS No.	666179-74-4
Molecular Formula	C23H27FN4O2 · HCl
Molecular Weight	447.95 g/mol (as hydrochloride salt)
Synonyms	Risperidone HCl; Risperidone Hydrochloride; 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 Hydrochloride; R 64766; R-64766; Risperdal (brand name derivative); 4H-Pyrido[1,2-a]pyrimidin-4-one, 6,7,8,9-tetrahydro-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-2-methyl-, hydrochloride
EINECS	Contact for details

Quality Control

Our Risperidone (Hydrochloride) is manufactured under strict quality systems to meet the rigorous standards of the pharmaceutical industry. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure compliance with pharmacopeial specifications (e.g., USP, EP) and internal quality standards. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and product integrity.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider using desiccants.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Heavy Metals	≤ 20 ppm

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