Description

3-(2-Chloroethyl)-2-Methyl-9-Hydroxy-4H-Pyrido[1,2-A]Pyrimidin-4-One (Paliperidone) is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) of significant commercial importance. This compound serves as the key chemical entity for the synthesis of paliperidone, a widely used atypical antipsychotic medication. It is essential for manufacturers in the pharmaceutical industry engaged in the production of finished dosage forms for the treatment of schizophrenia and related disorders. Our supply is characterized by stringent quality control to ensure batch-to-batch consistency and compliance with global regulatory standards.

Application

• Primary Active Pharmaceutical Ingredient (API): Direct synthesis of paliperidone for antipsychotic medications.
• Pharmaceutical R&D: Critical intermediate in the research and development of new neuropsychiatric drug candidates and formulations.
• Generic Drug Manufacturing: Sourcing for the production of generic paliperidone tablets and extended-release formulations.
• Reference Standard: Used as a high-purity chemical reference standard in analytical laboratories for quality control and method validation.
• Process Chemistry: Key building block in complex multi-step organic syntheses within fine chemical and contract manufacturing organizations (CMOs).

Basic Information

Product Name	3-(2-Chloroethyl)-2-Methyl-9-Hydroxy-4H-Pyrido[1,2-A]Pyrimidin-4-One (Paliperidone)
CAS No.	260273-82-3
Molecular Formula	C16H17ClN2O2
Molecular Weight	304.77 g/mol
Synonyms	Paliperidone; 9-Hydroxyrisperidone; 9-OH-Risperidone; 3-(2-Chloroethyl)-2-methyl-9-hydroxy-4H-pyrido[1,2-a]pyrimidin-4-one; (RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one (related parent compound); INVEGA API Intermediate
EINECS	Contact for details

Quality Control

Our 3-(2-Chloroethyl)-2-Methyl-9-Hydroxy-4H-Pyrido[1,2-A]Pyrimidin-4-One is produced under a strict quality management system. Every batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR spectroscopy, to ensure it meets exacting specifications for pharmaceutical use. Certificates of Analysis (COA) documenting all critical quality attributes are provided and can be tailored to support regulatory filings for markets requiring compliance with ICH Q7, GMP, and relevant pharmacopeial guidelines (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). The product is light-sensitive (store away from light). Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white 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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%
Residue on Ignition	≤0.1%

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