Description

Mizolastine Impurity 9 CAS NO 935860-13-2 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 antihistamine drug Mizolastine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of Mizolastine-related impurities.
• Analytical Method Development in HPLC, LC-MS, and GC-MS for quality control laboratories.
• Impurity Profiling and Characterization to meet ICH Q3A/B guidelines for drug substance and product registration.
• Stability Studies to monitor the formation of degradation products in Mizolastine formulations.
• Pharmacopoeial Testing to support compliance with USP, EP, or other pharmacopoeia monographs.
• Research and Development of Mizolastine synthesis pathways and impurity fate mapping.

Basic Information

Product Name	Mizolastine Impurity 9
CAS No.	935860-13-2
Molecular Formula	C24H25FN4O
Molecular Weight	404.48 g/mol
Synonyms	Mizolastine Related Compound 9; Mizolastine EP Impurity 9; Mizolastine USP Impurity 9; 2-[[1-[1-[(4-Fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]pyrimidin-4(3H)-one; 1H-Benzimidazole, 1-[(4-fluorophenyl)methyl]-2-[4-[[(4-oxo-3,4-dihydro-2-pyrimidinyl)amino]methyl]-1-piperidinyl]-
EINECS	Contact for details

Quality Control

Every batch of Mizolastine Impurity 9 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with industry standards and customer-specific requirements. Certificates of Analysis (COA) with detailed chromatographic purity, identity confirmation, and batch-specific data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.

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 individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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