Description

Paliperidone Impurity 6 is a designated process-related impurity and degradation product of the atypical antipsychotic drug Paliperidone. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a certified reference standard in method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification, qualification, and quantification of Paliperidone Impurity 6 in Paliperidone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC 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 to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity during Paliperidone manufacturing.

Basic Information

Product Name	Paliperidone Impurity 6
CAS No.	1268058-08-7
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	Paliperidone Related Compound 6; 9-Hydroxyrisperidone Impurity 6; 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; 9-Hydroxy-3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidinyl]ethyl]-2-methyl-4H,6H,7H,8H,9H-pyrido[1,2-a]pyrimidin-4-one; Paliperidone EP Impurity G; Paliperidone USP Impurity 6
EINECS	Contact for details

Quality Control

Our Paliperidone Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and traceable lot-specific results are provided to support your regulatory and QC needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This 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
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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