Description

Mizolastine Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the antihistamine drug Mizolastine. This high-purity reference material is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling accurate identification and quantification of this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, production, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) used in impurity profiling.
• Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods to separate and quantify Mizolastine Impurity 7 from the active pharmaceutical ingredient (API) and other related substances.
• Quality Control & Batch Release: Used in routine quality control testing of Mizolastine API and finished drug products to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the Mizolastine API.

Basic Information

Product Name	Mizolastine Impurity 7
CAS No.	935860-15-4
Molecular Formula	C24H25FN4O
Molecular Weight	404.48 g/mol
Synonyms	2-[[1-[1-[(4-Fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]pyrimidin-4(3H)-one; Mizolastine Related Compound 7; Mizolastine EP Impurity G; Mizolastine USP Impurity; Degradation product of Mizolastine; 4(3H)-Pyrimidinone, 2-[[1-[1-[(4-fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]-
EINECS	Contact for details

Quality Control

Every batch of Mizolastine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP/EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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