Description

Pimavanserin Impurity 20 is a designated reference standard used in the analytical profiling and quality control of the atypical antipsychotic drug, Pimavanserin. This high-purity compound is critical for pharmaceutical development and manufacturing, enabling precise identification, quantification, and control of this specific impurity to ensure drug safety and efficacy. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Quantitative and qualitative analysis in HPLC and LC-MS systems for impurity profiling of Pimavanserin API and finished dosage forms.
• Critical component in establishing specification limits and meeting ICH Q3A/B guidelines for impurities in new drug substances and products.
• Essential for stability studies to monitor impurity levels over the shelf-life of the drug product.
• Used in pharmacopoeial testing and compliance with regulatory submissions (e.g., FDA, EMA).
• Serves as a system suitability test component in quality control laboratories.

Basic Information

Product Name	Pimavanserin Impurity 20
CAS No.	1387104-81-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pimavanserin Related Compound 20; Pimavanserin EP Impurity J; Pimavanserin USP Impurity; 1-(4-Fluorobenzyl)-3-(4-(2-methylpropoxy)benzyl)urea Impurity; NUPLAZID Impurity 20; ACP-103 Impurity 20
EINECS	Contact for details

Quality Control

Every batch of Pimavanserin Impurity 20 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to support pharmaceutical applications, with testing typically including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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