Description

Blonanserin Impurity CAS NO 132810-83-4 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 manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Blonanserin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Blonanserin formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances.
• Quality Control Testing: Acts as a system suitability standard and for routine batch release testing of Blonanserin API.

Basic Information

Product Name	Blonanserin Impurity
CAS No.	132810-83-4
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; Blonanserin Related Compound; AD-5423 Impurity; Lonasen Impurity; Blonanserin EP Impurity; Blonanserin USP Impurity; Blonanserin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Blonanserin Impurity (CAS 132810-83-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profile testing using advanced techniques like HPLC and GC-MS to ensure compliance with pharmacopeial standards (USP/EP). 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%

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