Description

Bilastine CAS NO 202189-78-4 is a potent, non-sedating second-generation antihistamine API (Active Pharmaceutical Ingredient). It is a highly selective H1-receptor antagonist, offering effective relief from allergic symptoms with a favorable safety profile. This compound is essential for pharmaceutical manufacturers developing advanced allergy and urticaria treatments, particularly in oral solid dosage forms like tablets and oral dispersible films.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and OTC anti-allergy medications.
• Allergic Rhinitis Treatment: Formulation into tablets and oral lyophilisates for seasonal and perennial allergic rhinitis.
• Chronic Spontaneous Urticaria Management: Key component in therapies for symptomatic relief of chronic hives and itching.
• Pediatric & Adult Formulations: Suitable for developing age-appropriate dosage forms due to its established efficacy and tolerability.
• Fixed-Dose Combination Drugs: Potential for combination with other APIs (e.g., decongestants) in multi-symptom allergy products.
• Generic Drug Manufacturing: Sourcing for cost-effective generic versions of branded bilastine products.

Basic Information

Product Name	Bilastine
CAS No.	202189-78-4
Molecular Formula	C28H37N3O3
Molecular Weight	463.61 g/mol
Synonyms	2-[4-(2-{4-[1-(2-Ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl}ethyl)phenyl]-2-methylpropanoic acid; Bilaxten (Trade Name); Ilaxten (Trade Name); BIL; Bilaxten; Non-sedating antihistamine API
EINECS	Contact for details

Quality Control

Our Bilastine is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via validated methods such as HPLC. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to ensure traceability and regulatory support for your manufacturing processes.

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 after opening to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

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