Description

Bilastine Impurity 19 is a specified impurity of the antihistamine drug Bilastine, identified by the CAS registry number 2099128-83-1. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Bilastine drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bilastine Impurity 19 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Bilastine.

Basic Information

Product Name	Bilastine Impurity 19
CAS No.	2099128-83-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bilastine Related Compound 19; Bilastine EP Impurity 19; Bilastine USP Impurity 19; 2-[4-(Diphenylmethoxy)piperidin-1-yl]ethyl 3-aminobenzoate; 3-Aminobenzoic acid 2-[4-(diphenylmethoxy)-1-piperidinyl]ethyl ester; Bilastine Impurity 19 (2099128-83-1); Bilastine Specified Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Bilastine Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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