Description

Blonanserin Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the antipsychotic drug substance Blonanserin. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final pharmaceutical product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Primary use as a certified reference standard for the identification and quantification of Blonanserin Impurity 15 in active pharmaceutical ingredients (APIs).
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical R&D and QC laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Serves as a critical component for regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports pharmacopoeial testing to ensure compliance with monographs from USP, EP, or other international standards.
• Employed in contract research organizations (CROs) and quality control laboratories for routine batch release testing.

Basic Information

Product Name	Blonanserin Impurity 15
CAS No.	143213-96-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Blonanserin Related Compound 15; Blonanserin EP Impurity C; Blonanserin USP Impurity; 2-(4-Ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine; AD-5423 Impurity; Lonasen Impurity
EINECS	Contact for details

Quality Control

Every batch of Blonanserin Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, MS, NMR, IR) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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. The material should be kept in a dry environment. 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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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