Description

Paliperidone Impurity 7 is a structurally defined pharmaceutical reference standard used for analytical method development, validation, and quality control of paliperidone-based drug substances and products. It plays a critical role in ensuring regulatory compliance and batch-to-batch consistency by enabling accurate identification and quantification of this specific degradation product or synthetic intermediate. Pharmaceutical manufacturers, contract research organizations (CROs), and regulatory testing laboratories rely on this impurity standard to meet stringent ICH Q3B(R3) guidelines for residual impurity profiling. Paliperidone Impurity 7 CAS NO 1415488-05-9 is essential for robust stability-indicating assays and pharmacopeial compliance.

Application

• Reference standard for HPLC and UPLC method validation in paliperidone API and finished dosage form testing
• Calibration material for quantitative determination of impurity levels per ICH Q2(R2) and USP <1058>
• Stability-indicating assay development to monitor paliperidone degradation pathways under stress conditions
• Qualification of impurity peaks during forced degradation studies (acid/base hydrolysis, oxidation, photolysis, thermal stress)
• Supporting regulatory submissions (FDA, EMA, PMDA) with fully characterized reference materials
• Use in pharmacopeial monograph compliance (USP-NF, Ph. Eur., JP) for paliperidone-related substances testing
• Proficiency testing and inter-laboratory comparison programs for pharmaceutical QC labs
• Internal quality assurance audits and GMP documentation for impurity control strategy implementation

Basic Information

Product Name	Paliperidone Impurity 7
CAS No.	1415488-05-9
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	9-Hydroxyrisperidone Impurity; 9-Hydroxypaliperidone; 9-Hydroxy-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-6,7,8,9-tetrahydro-2H-pyrido[1,2-a]pyrimidin-2-one; (±)-9-Hydroxypaliperidone; Paliperidone 9-OH Impurity; Paliperidone Hydroxy Impurity; Risperidone 9-Hydroxy Metabolite Impurity; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-6,7,8,9-tetrahydro-2H-pyrido[1,2-a]pyrimidin-2-one
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is tested per ICH Q5C and Q5D guidelines for identity, purity, and structural integrity. Testing includes HPLC purity assessment, NMR and IR spectral confirmation, residual solvent analysis (GC), and water content determination (Karl Fischer). All materials are manufactured under ISO 9001-certified quality management systems and support GMP-compliant pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent degradation. Due to its hygroscopic nature, maintain low humidity conditions (<30% RH) and minimize exposure to ambient air during handling.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Single impurity ≤0.3%; Total impurities ≤0.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤10 ppm

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