Description

Pimavanserin Impurity 13 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pimavanserin. This high-purity compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of specific process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on drug development and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and assay of Pimavanserin Impurity 13 in drug substance and drug product.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for Pimavanserin.
• Stability Studies & Degradation Profiling: Used to monitor impurity levels during forced degradation and long-term stability studies of Pimavanserin API and formulations.
• Regulatory Submission & Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies as per ICH Q3A/B guidelines.
• Process Chemistry & Optimization: Helps in monitoring and controlling the formation of this impurity during the synthesis and purification stages of Pimavanserin manufacturing.
• Quality Control Testing: Serves as a system suitability and quantitation standard in routine QC release testing of Pimavanserin batches.

Basic Information

Item	Detail
Product Name	Pimavanserin Impurity 13
CAS No.	1399883-72-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pimavanserin Related Compound 13; 1-(4-Fluorobenzyl)-3-(4-(2-methylpropoxy)benzyl)urea Impurity; NUPLAZID Impurity 13; ACP-103 Impurity 13; UNII-Contact for details; (4-Fluorophenyl)methanamine Impurity; Urea Derivative Impurity of Pimavanserin
EINECS	Contact for details

Quality Control

Every batch of Pimavanserin Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Comprehensive characterization is performed using advanced analytical techniques including HPLC, GC, MS, and NMR. Certificates of Analysis (COA) detailing purity, identity, and traceability are available upon request.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.