Description

Paliperidone Impurity 14 is a designated process-related impurity or degradation product of the atypical antipsychotic drug, Paliperidone. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories and manufacturers to ensure the purity, safety, and efficacy of Paliperidone API and its finished dosage forms. This high-purity standard is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs.

Application

• Primary use as a certified reference standard for the identification and quantification of Paliperidone Impurity 14 in active pharmaceutical ingredient (API) batches.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) to meet ICH Q2(R1) and other regulatory guidelines.
• Used in stability studies and forced degradation studies to profile impurity formation pathways in Paliperidone formulations.
• Essential for quality control and release testing to ensure API and drug product specifications comply with pharmacopeial standards (USP, EP).
• Supports regulatory submissions (e.g., ANDA, NDA) by providing impurity data for drug master files.
• Valuable for research and development of synthetic routes and process optimization to minimize this specific impurity.

Basic Information

Product Name	Paliperidone Impurity 14
CAS No.	118873-18-0
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	9-Hydroxyrisperidone Impurity 14; Paliperidone Related Compound 14; 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 Risperidone Impurity 14; Paliperidone EP Impurity H; Paliperidone USP Related Compound
EINECS	Contact for details

Quality Control

Every batch of Paliperidone Impurity 14 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial and in-house specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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