Description

Mizolastine Impurity N is a high-purity 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: Used as a certified reference material (CRM) for the identification and quantification of Mizolastine Impurity N in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities during Mizolastine synthesis and formulation.
• Quality Control & Assurance: Serves as a critical benchmark in QC laboratories to ensure drug substance and drug product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to establish drug shelf life.
• Regulatory Submissions: Required for compiling impurity data in regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive control of the drug's impurity profile.
• Research & Development: Used in pharmaceutical R&D to study the metabolic pathways, degradation mechanisms, and toxicological profiles associated with Mizolastine impurities.

Basic Information

Product Name	Mizolastine Impurity N
CAS No.	108612-60-8
Molecular Formula	C24H25FN4O
Molecular Weight	404.48 g/mol
Synonyms	Mizolastine Related Compound N; Mizolastine EP Impurity N; Mizolastine USP Impurity N; 2-[[1-[1-[(4-Fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]-4(1H)-pyrimidinone; UNII-9F4W8C6T8I
EINECS	Contact for details

Quality Control

Every batch of Mizolastine Impurity N is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards for pharmaceutical impurities.

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); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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