Description

Blonanserin Impurity 10 is a specified impurity and degradation product of the antipsychotic drug Blonanserin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Blonanserin drug substances and finished products. This high-purity impurity standard is primarily utilized by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Blonanserin Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure drug substance and product batches comply with stringent pharmacopeial (e.g., ICH Q3A/B) and internal specification limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this impurity during Blonanserin manufacturing.

Basic Information

Product Name	Blonanserin Impurity 10
CAS No.	132810-87-8
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 Degradation Product; Blonanserin Process Impurity; 4-(4-Fluorophenyl)-2-(4-ethylpiperazin-1-yl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine
EINECS	Contact for details

Quality Control

Every batch of Blonanserin Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity, assay, and identification data. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for impurities in new drug substances and products.

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 desiccation.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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