Description

Blonanserin Impurity I is a specified impurity and a key reference standard used in the analytical profiling of the antipsychotic drug Blonanserin. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of the final drug substance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, process validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Blonanserin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions as part of forced degradation and shelf-life studies.
• Process Chemistry Research: Used in research to understand and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Blonanserin Impurity I
CAS No.	49860-76-6
Molecular Formula	C23H30FN3O
Molecular Weight	383.51 g/mol
Synonyms	2-(4-Ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine; AD-5423 Impurity; Blonanserin Related Compound I; 4-(4-Fluorophenyl)-2-(4-ethylpiperazin-1-yl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine; Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-
EINECS	Contact for details

Quality Control

Every batch of Blonanserin Impurity I is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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