Description

Paliperidone Impurity 11 is a designated impurity standard used in the pharmaceutical development and quality control of the antipsychotic drug Paliperidone. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Paliperidone Impurity 11 in active pharmaceutical ingredients (API) and finished drug products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Paliperidone API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity during manufacturing.

Basic Information

Product Name	Paliperidone Impurity 11
CAS No.	130049-77-3
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	9-Hydroxyrisperidone Impurity 11; Paliperidone Related Compound 11; 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; (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-2,9-dihydroxy-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one; Risperidone Metabolite Impurity
EINECS	Contact for details

Quality Control

Every batch of Paliperidone Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

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

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