Description

Bilastine-D6 is a stable isotope-labeled analog of the non-sedating antihistamine Bilastine, specifically deuterated at six positions. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative analytical methods. It is primarily utilized by pharmaceutical research and development laboratories, as well as quality control departments, for applications requiring precise internal standardization. The compound is critical for method validation, pharmacokinetic studies, and ensuring regulatory compliance in drug development and manufacturing.

Application

• Internal standard for the quantitative analysis of Bilastine in biological matrices (e.g., plasma, serum) using LC-MS/MS.
• Reference material for method development and validation in pharmaceutical quality control (QC) laboratories.
• Critical component in pharmacokinetic and bioequivalence studies to ensure accurate drug concentration measurements.
• Use in metabolic stability studies and drug metabolism research to track the parent compound.
• Calibration standard for ensuring the precision and accuracy of analytical instrumentation.
• Essential material for regulatory submissions to agencies like the FDA and EMA, supporting drug approval processes.

Basic Information

Product Name	Bilastine-D6
CAS No.	1215358-58-9
Molecular Formula	C28H31D6N3O3
Molecular Weight	473.66 g/mol
Synonyms	2-[4-(2-{4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl}ethyl)phenyl]-2-methylpropanoic Acid-d6; Bilastine (hexadeuterated); Bilastine-d6 (hexadeuterated); Bilaxten-d6; Ilaxten-d6; Deuterated Bilastine; Bilastine Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Bilastine-D6 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes data for identity, purity (by HPLC), isotopic enrichment, and residual solvents. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications, ensuring traceability and reliability for your critical research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥98.0% (Chemical Purity)
Isotopic Purity (Deuterium Enrichment)	≥98.0 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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