Description

Bilastine Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antihistamine drug Bilastine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Bilastine Impurity 20 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities during Bilastine manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical component in routine batch release testing to ensure drug purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop improved purification processes.

Basic Information

Product Name	Bilastine Impurity 20
CAS No.	2411093-91-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bilastine Related Compound 20; Bilastine EP Impurity J; Bilastine USP Impurity; Bilastine Process Impurity; 2-[4-[(4-Fluorophenyl)methyl]-1-piperazinyl]-N-(4-methoxyphenyl)acetamide Impurity; (R)-Bilastine Impurity; Desmethyl Bilastine Impurity
EINECS	Contact for details

Quality Control

Every batch of Bilastine Impurity 20 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters as per ICH guidelines.

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. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.