Bilastine API Specification Sheet: What Every Buyer Must Verify Before Sourcing
Bilastine Specification Sheet: Trusted API Global Supply
Bilastine (CAS: 202189-78-4) is a modern second-generation antihistamine known for its selective H1 receptor blocking, non-sedative effects, and strong safety profile, making it increasingly popular worldwide.
For pharma companies and buyers, finding a reliable Bilastine API source means looking beyond suppliers to true partners with technical expertise, regulatory know-how, and a commitment to quality.
This article offers an in-depth look at the Bilastine Specification Sheet, outlines critical aspects of sourcing Bilastine for pharmaceutical manufacturing, and introduces.
Bio-Synth, a leader among India’s pharmaceutical ingredient suppliers, with over 80 years of heritage in API production and international distribution.
What Is Bilastine and Why Is It in Demand?
Bilastine API is an orally active, non-sedating antihistamine used primarily for the treatment of allergic rhinitis and urticaria.
It has a long duration of action (up to 24 hours), rapid onset (within 1 hour), and does not cross the blood-brain barrier to a significant extent, minimizing central side effects like drowsiness.
Key Technical Identifiers
| Parameter | Details |
| API Name | Bilastine |
| CAS Number | 202189-78-4 |
| Molecular Formula | C28H37N5O3 |
| Molar Mass | 491.63 g/mol |
| Therapeutic Use | Antihistamine (Non-sedating) |
| Application | Allergic Rhinitis, Chronic Spontaneous Urticaria |
| Pharmacopoeial Status | Under monograph development (non-compendial in some markets) |
Common Synonyms
Bilaxten
Ilaxten
Bilastine [INN]
2-[4-[2-[4-[1-(2-ethoxyethyl)benzimidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic acid
Bilastine Specification Sheet: Manufacturing Insights
Bio-Synth’s Bilastine API Technical Specifications
Bio-Synth ensures all manufactured APIs meet strict international and pharmacopoeial standards. Below is a snapshot of our Bilastine specification sheet:
| Specification Parameter | Bio-Synth Standard |
| Appearance | White to off-white powder |
| Assay (HPLC) | ≥98.5% |
| Water Content (KF) | NMT 1.0% |
| Related Substances | NMT 0.1% (each impurity); NMT 1.0% (total) |
| Melting Point | 190–195°C |
| Specific Optical Rotation | As per the internal specification |
| Residual Solvents | As per ICH Q3C guidelines |
| Heavy Metals | NMT 10 ppm |
| Shelf Life | 36 months (under recommended storage) |
Why Bio-Synth Is the Preferred GMP-Certified API Manufacturer in India
With 80+ years of consistent innovation and technical excellence, Bio-Synth stands as one of India’s most reputed GMP-certified API exporters.
We operate a WHO-GMP-certified facility in Hyderabad dedicated to the manufacture of high-quality pharmaceuticals, including Bilastine and APIs across various therapeutic areas.
Core Strengths of Bio-Synth
- Legacy in Pharma Manufacturing: Founded in 1943, Bio-Synth brings an unmatched heritage in active pharmaceutical ingredient synthesis and quality control.
- Therapeutic Segment Diversification:
- Anti-TB APIs: PAS Sodium, Bedaquiline
- Cardiovascular Drugs
- Antipsychotics
- Anti-diabetic APIs
- Antihistamines including Bilastine
- Certifications & Compliance:
- WHO-GMP Certified
- ISO 9001:2015 Compliant
- Adherence to ICH Q7, ICH Q3C, and Q8-Q10 guidelines
- Export Footprint: Serving clients across Europe, Asia-Pacific, MENA
- Scalability: Manufacturing capacities from kilo-scale to multi-ton scale under robust quality systems
India’s Role in Global API Sourcing: Strategic Benefits for Buyers
The Indian pharmaceutical industry supplies over 20% of global generics and 60% of all vaccines.
When sourcing Bilastine or any antihistamine API, working with a trusted pharma manufacturer in India can unlock strategic benefits like cost efficiency, quality reliability, and strong regulatory readiness.
Why Choose an Indian API Manufacturer Like Bio-Synth?
- GMP Certified Bulk APIs Manufacturing supported by validated synthetic routes
- Flexible batch volumes catering to early-stage development through to commercial scale
- Robust regulatory documentation for DMF submissions (USDMF, EU-CTD, JAPAN-DMF)
- Cost-effective logistics supported by decades of export experience
- In-house R&D to innovate impurity profiling, synthesis pathways, and analytical validations
Quality Assurance and Consistency Across Batches
Consistency in API quality is critical for formulators and final dosage manufacturers. At Bio-Synth, a dedicated Quality Assurance and Quality Control (QA-QC) team ensures:
- Batch-to-batch consistency validated via retrospective trend analysis
- Impurity profiling using HPLC/GC/MS technologies
- Accelerated and long-term stability testing
- Control over polymorphic forms and particle size distribution
- Real-time and stability data submitted wherever needed for regulatory filings
Documentation and Regulatory Support
Our Bilastine API is supplied with the following technical documentation:
- Certificate of Analysis (COA)
- Batch Manufacturing Record (BMR)
- Material Safety Data Sheet (MSDS)
- Stability Data (ICH Zones)
- Method of Analysis (MoA)
- Regulatory filings support upon request (DMF/CTD)
In addition, Bio-Synth is capable of supporting pharma clients with:
- Custom impurity standards
- Process development support
- End-to-end tech transfer
Market Trends: Bilastine API Price and Global Demand Forecast
Key Market Drivers
- Increase in allergic reactions and environmental allergens
- Preference for second-generation antihistamines
- Growing demand for non-sedating H1 blockers
Price Dynamics
While Bilastine API prices fluctuate based on raw material index, purity specifications, and order volume, Bio-Synth offers transparent pricing aligned with international benchmarks. Our procurement partners appreciate:
- Volume-based pricing support
- Long-term contract discounts
- Direct manufacturer deal, no intermediary cost inflation
Therapeutic Segments Covered by Bio-Synth APIs
| Therapeutic Area | Flagship APIs |
| Anti-TB | Bedaquiline, PAS Sodium |
| Cardiovascular | Carvedilol |
| Antihistamines | Bilastine |
| Antipsychotics | Amisulpride |
| Anti-Diabetics | Empagliflozin, Dapagliflozin |
Why Bilastine Buyers Choose Bio-Synth
Whether you’re a formulation scientist, procurement manager, or regulatory affairs officer, Bio-Synth offers:
- Regulatory-prepared Bilastine API, fully documented
- Flexible MOQ and bulk packaging
- On-time delivery across global locations
- In-house analytical and compliance support
- Custom manufacturing feasibility for Bilastine derivatives or related intermediates
Partner with Bio-Synth: India’s Trusted API Manufacturer
As a globally recognized pharmaceutical ingredient supplier with 8 decades of manufacturing legacy, Bio-Synth is your ideal manufacturing partner for Bilastine API and a wide range of APIs spanning critical therapeutic needs.
Contact Bio-Synth today for custom quotes, Bilastine COAs, or regulatory documentation.
Our technical team will help you streamline your procurement with accuracy and confidence. Let us support your development, stability, and regulatory success.
👉 Request a sample or speak to our technical sales team at Bio-synth
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