Description

Paliperidone Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) paliperidone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Paliperidone API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to understand and control impurity formation pathways during the manufacturing process.

Basic Information

Product Name	Paliperidone Impurity 12
CAS No.	1117803-76-5
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	9-Hydroxyrisperidone Impurity 12; Paliperidone Related Compound 12; 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; Risperidone metabolite impurity; Paliperidone process impurity
EINECS	Contact for details

Quality Control

Every batch of Paliperidone Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a reference standard for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.