Description

Blonanserin Impurity 15 is a designated reference standard used in the analytical profiling and quality control of the antipsychotic drug Blonanserin. This high-purity chemical is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It serves as a key marker for identifying and quantifying specific process-related impurities during drug development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Blonanserin Impurity 15 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure Blonanserin API meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a benchmark to track the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Research & Development (R&D): Utilized in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Blonanserin Impurity 15
CAS No.	132813-16-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-(4-Ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine; Blonanserin Related Compound 15; Blonanserin EP Impurity C; AD-5423 Impurity; Lonasen Impurity
EINECS	Contact for details

Quality Control

Every batch of Blonanserin Impurity 15 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure compliance with high-grade reference standard specifications. 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). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator after opening.

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 ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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