Description

Mizolastine Impurity 11 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Mizolastine, a second-generation antihistamine. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method validation, impurity profiling, and stability studies. Ensuring the identity and purity of this impurity is essential for drug safety and meeting stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Mizolastine.
• Impurity Profiling: Essential for identifying and quantifying process-related impurities in Mizolastine active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Serves as a critical component in developing and validating analytical methods, particularly HPLC and LC-MS.
• Stability Studies: Used to monitor the formation of degradation products in Mizolastine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Quality Assurance/Quality Control (QA/QC): Employed in routine QC testing to ensure Mizolastine API and finished products meet specified purity criteria.

Basic Information

Product Name	Mizolastine Impurity 11
CAS No.	1569097-23-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mizolastine Related Compound 11; Mizolastine EP Impurity J; Mizolastine USP Impurity; 2-[[1-[1-[(4-Fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]pyrimidin-4(3H)-one; Mizolastine Degradant; Mizolastine Process Impurity
EINECS	Contact for details

Quality Control

Our Mizolastine Impurity 11 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment ensures the material is suitable for its intended use as a pharmaceutical reference standard.

Storage

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

Specification

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

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