Description

1'-Hydroxy Bilastine 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 in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development and quality control of advanced antihistamine medications.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and scale-up production of the active pharmaceutical ingredient Bilastine.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify metabolites in pharmacokinetic and pharmacodynamic research.
• Drug Impurity Profiling: Essential for method development and validation in HPLC and LC-MS to monitor and control related substances in Bilastine API batches.
• Preclinical and Clinical Research: Supports investigative studies on the metabolic pathways, efficacy, and safety profile of Bilastine.
• Quality Control & Assurance: Serves as a certified reference material (CRM) for in-house testing and compliance with pharmacopoeial standards (e.g., USP, EP).

Basic Information

Product Name	1'-Hydroxy Bilastine
CAS No.	1638785-23-5
Molecular Formula	C28H37N3O3
Molecular Weight	463.61 g/mol
Synonyms	1'-Hydroxybilastine; Bilastine 1'-Hydroxy Metabolite; 2-[4-(2-{4-[1-Hydroxy-1-(4-methylphenyl)ethyl]piperidin-1-yl}ethyl)phenyl]-2-methylpropanoic Acid; UNII-7F4A8WY3QN; 7F4A8WY3QN; BILA 1'-OH; Bilastine Hydroxy Metabolite
EINECS	Contact for details

Quality Control

Our 1'-Hydroxy Bilastine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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