Bilastine API Specification Sheet: What Every Buyer Must Verify Before Sourcing

Bilastine is a second-generation antihistamine API, CAS 202189-78-4, supplied as a white to yellowish powder and manufactured by Bio-Synth in Hyderabad. Before ordering, check three things: the grade named on the certificate of analysis, the release limit behind every test on it, and whether the GMP certificate you were shown lists this product on its schedule.

What Bilastine Is

Bilastine API treats allergic rhinoconjunctivitis and other forms of allergic rhinitis. One dose a day, tablet or oral solution, working within about 20 minutes. It crosses the blood-brain barrier only to a limited extent, so it avoids the sedation of first-generation H1 antihistamines. Bilastine uses in allergy treatmentcover the pharmacology.

Technical Identifiers

Bilastine contains no halogen. The formula on the Bilastine API page carries a stray bromine, while the 463.62 beside it is the weight of the bromine-free molecule.

What the Specification Controls

Every test exists because something can go wrong at that point in the process. Identification confirms the drum holds Bilastine. Assay by HPLC says how much active you get per kilogram. Related substances cover process impurities and degradants under ICH Q3A, residual solvents under ICH Q3C, and elemental impurities under ICH Q3D. Water by Karl Fischer drives both stability and the assay.

Two get skipped and shouldn’t. Particle size and polymorphic form decide dissolution downstream. Bilastine Form I vs Form II explains the difference. The retest period says how long the material holds specification.

Bilastine is supplied against IP and in-house specifications. Where no monograph governs a test, the manufacturer sets the limit and justifies it with development and stability data. Ask for the justification, not just the number.

Bilastine IP Specification

Reading the Certification Correctly

Site-level is not product-level. ISO 9001:2015 certifies a quality management system. A WHO-GMP certificate is issued by a state licensing authority against a named schedule of products, so the question is never “are you WHO-GMP certified” – it is “which products are on the schedule attached to your current certificate”.

Bio-Synth manufactures at a licensed Balanagar site in Hyderabad under the Drugs and Cosmetics Act, 1940, working to ICH Q7 principles, with a quality management system certified to ISO 9001:2015 whose scope names the development, manufacture, and sale of active pharmaceutical ingredients and drug intermediates. Bilastine API certifications lists the documents worth collecting.

Before You Order

• A batch-specific certificate of analysis for your grade, not a typical CoA.
• Which tests on it are pharmacopoeial, which are in-house, and what the in-house limits rest on.
• The safety data sheet and the analytical methods needed to verify the material on receipt.
• Stability data for your storage zone and packing, plus the quality systems behind it.
• Pack size, liner and retest-date handling, agreed in writing.

Price follows from all of it — grade, impurity profile, order size, packing and documentation depth each move the per-kilogram number, which Bilastine API price breaks down.

For a quote against your own specification,contact Bio-Synth with grade, annual volume and destination market.