Description

Bilastine n-Oxide CAS NO 2069238-47-5 is a key pharmaceutical intermediate and metabolite of the non-sedating antihistamine Bilastine. This compound is of significant importance for research and development in the pharmaceutical industry, particularly for metabolic studies, impurity profiling, and analytical method development. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on developing and validating new antihistamine therapies and ensuring drug safety and quality.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bilastine metabolites in pharmacokinetic and bioanalytical studies.
• Impurity Profiling: Used as a specified impurity standard to monitor and control the quality of Bilastine active pharmaceutical ingredient (API) during manufacturing, in compliance with ICH guidelines.
• Metabolic Pathway Research: A critical tool for in vitro and in vivo studies investigating the biotransformation and excretion pathways of Bilastine.
• Analytical Method Development: Essential for developing and validating HPLC, LC-MS, and other chromatographic methods for the accurate analysis of Bilastine and its related substances.
• Drug Safety and Toxicology Studies: Employed in preclinical and clinical studies to assess the safety profile and potential biological activity of Bilastine metabolites.
• Regulatory Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on drug impurities and degradation products.

Basic Information

Product Name	Bilastine n-Oxide
CAS No.	2069238-47-5
Molecular Formula	C28H37N3O4
Molecular Weight	479.62 g/mol
Synonyms	Bilastine N-Oxide; Bilastine Impurity; Bilastine Metabolite; 2-[4-(2-{4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl}ethyl)phenyl]-2-methylpropanoic Acid N-Oxide; 4-[2-[4-[1-(2-Ethoxyethyl)benzimidazol-2-yl]-1-piperidyl]ethyl]-α,α-dimethylphenylacetic Acid N-Oxide; UNII-1F8Z2K6Q3V; BILA N-Oxide
EINECS	Contact for details

Quality Control

Our Bilastine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B guidelines 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. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

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

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