Description

Paliperidone Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the antipsychotic drug Paliperidone. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and commercial production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Paliperidone Impurity 4 in drug substance and finished product analysis.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure Paliperidone API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as an analytical marker to track impurity profiles in stability-indicating methods for drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Paliperidone Impurity 4
CAS No.	152542-03-5
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	9-Hydroxyrisperidone Impurity 4; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-2,9-dihydroxy-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one; Paliperidone Related Compound 4; Paliperidone EP Impurity D; Risperidone Metabolite Impurity
EINECS	Contact for details

Quality Control

Our Paliperidone Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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