Description

Mizolastine Impurity 8 CAS NO 935860-12-1 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antihistamine drug Mizolastine. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure the safety, efficacy, and regulatory compliance of their final drug product. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Mizolastine.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels in active pharmaceutical ingredients (APIs) and finished drug products to meet ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to identify and quantify degradation products that may form under various stress conditions during drug shelf-life studies.
• Research and Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Mizolastine Impurity 8
CAS No.	935860-12-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mizolastine Related Compound 8; Mizolastine EP Impurity 8; Mizolastine USP Impurity 8; Mizolastine Process Impurity; 2-[[1-[1-[(4-Fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]pyrimidin-4(3H)-one (probable structure based on naming convention); Mizolastine Specified Impurity; Mizolastine Degradant
EINECS	Contact for details

Quality Control

Every batch of Mizolastine Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (such as USP and EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 (moisture-sensitive) nature, the container must be kept in a dry environment and sealed immediately after use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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