Description

Blonanserin Impurity 21 is a designated reference standard used in the analytical profiling and quality control of the antipsychotic drug Blonanserin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development and validation of analytical methods for identifying and quantifying process-related impurities.

Application

• As a pharmaceutical reference standard for analytical method development and validation (HPLC, LC-MS).
• For quality control and assurance in the manufacturing of Blonanserin Active Pharmaceutical Ingredient (API).
• In impurity identification and characterization studies to meet ICH guidelines.
• Used in stability testing and degradation pathway studies of Blonanserin formulations.
• As a critical reagent in regulatory filing and submission documentation for drug approval.
• For research and development purposes in synthetic chemistry and pharmacology.

Basic Information

Product Name	Blonanserin Impurity 21
CAS No.	848301-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Blonanserin Related Compound 21; Blonanserin Specified Impurity 21; 2-(4-Ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine; UNII-9M3Y7V6F4I; Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-; ADL-21; Blonanserin Impurity ADL 21
EINECS	Contact for details

Quality Control

Our Blonanserin Impurity 21 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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