Description

Mizolastine Impurity 5 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 for the identification and quantification of impurities in Mizolastine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and validation in Quality Control (QC) laboratories to establish impurity limits and ensure batch-to-batch consistency.
• Regulatory Compliance and Documentation, supporting submissions to agencies like the FDA and EMA by providing characterized impurity data.
• Stability Studies to monitor the formation of this specific degradation product under various stress conditions.
• Research and Development for studying the metabolic pathways, degradation mechanisms, and toxicological profile of Mizolastine.

Basic Information

Item	Detail
Product Name	Mizolastine Impurity 5
CAS No.	32833-13-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mizolastine Related Compound 5; Mizolastine Impurity C; 2-[[1-[1-[(4-Fluorophenyl)methyl]-1H-benzimidazol-2-yl]-4-piperidinyl]methylamino]pyrimidin-4(3H)-one; 1-[(4-Fluorophenyl)methyl]-2-[4-[(4-oxo-3,4-dihydropyrimidin-2-yl)methylamino]piperidin-1-yl]-1H-benzimidazole
EINECS	Contact for details

Quality Control

Our Mizolastine Impurity 5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests such as HPLC purity, related substances, and spectroscopic identification, supporting compliance with ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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