Description

Mizolastine CAS NO 108612-45-9 is a selective, non-sedating histamine H1-receptor antagonist. This compound is a key active pharmaceutical ingredient (API) valued for its potent and specific antihistaminic activity. It is primarily required by pharmaceutical manufacturers for the development and production of advanced allergy and asthma medications.

Application

• Primary Active Pharmaceutical Ingredient (API) in antihistamine medications.
• Key intermediate in the synthesis of advanced pharmaceutical formulations targeting allergic rhinitis and chronic urticaria.
• Research and development of new therapeutic agents for mast cell-mediated disorders.
• Reference standard in analytical laboratories for quality control and method validation.
• Used in preclinical and clinical studies investigating H1-receptor pharmacology.

Basic Information

Product Name	Mizolastine
CAS No.	108612-45-9
Molecular Formula	C24H25FN6O
Molecular Weight	432.50 g/mol
Synonyms	Mizollen; SL 85.0324; 2-[[1-[1-(4-Fluorophenyl)-1H-benzimidazol-2-yl]piperidin-4-yl]methylamino]pyrimidin-4(3H)-one; 2-({[1-(4-Fluorophenyl)-1H-1,3-benzodiazol-2-yl]-4-piperidinyl}methylamino)-4(1H)-pyrimidinone; 4(1H)-Pyrimidinone, 2-[[1-[1-(4-fluorophenyl)-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]-
EINECS	Contact for details

Quality Control

Our Mizolastine is manufactured under strict quality management systems, ensuring it meets the high-purity standards required for pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We adhere to relevant ICH guidelines and support compliance with cGMP standards for API manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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