Description

Blonanserin Impurity 2 CAS NO 1071664-63-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antipsychotic drug Blonanserin. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Blonanserin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for accurate impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Blonanserin batches meet stringent pharmacopeial (e.g., USP, EP, JP) and internal purity specifications.
• Stability Studies and Degradation Pathway Analysis: Employed to monitor impurity levels over time under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Submission and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research on Drug Metabolism and Pharmacokinetics (DMPK): Can be utilized in studies to understand the metabolic pathways and pharmacokinetic behavior of Blonanserin and related compounds.

Basic Information

Product Name	Blonanserin Impurity 2
CAS No.	1071664-63-5
Molecular Formula	C23H30FN3O
Molecular Weight	383.50 g/mol
Synonyms	2-(4-Ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine; Blonanserin Related Compound 2; Blonanserin EP Impurity B; Blonanserin USP Impurity; AD-5423 Impurity; Lonasen Impurity
EINECS	Contact for details

Quality Control

Every batch of Blonanserin Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and other relevant regulatory frameworks.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

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)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Assay	97.0% - 103.0% (on anhydrous basis)

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