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Betahistine Dihydrochloride API is a histamine analog and vasodilator used primarily in the management of Meniere’s disease and vestibular vertigo. It improves microcirculation in the inner ear, helping to reduce dizziness, tinnitus, and hearing loss associated with vestibular disorders.
At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Betahistine Dihydrochloride Active Pharmaceutical Ingredient (API). Our API meets IP, BP, and USP pharmacopeial standards and is produced under stringent quality control to ensure high purity, consistent particle size, and excellent stability for formulation use.
Betahistine Dihydrochloride is widely used in oral solid formulations such as tablets and capsules, and sometimes in oral solutions. It is a well-tolerated and effective treatment option for chronic balance disorders and inner ear dysfunction.
Therapeutic Applications:
- Meniere’s disease (vertigo, tinnitus, hearing loss)
- Vestibular vertigo and dizziness
- Balance disorders due to inner ear dysfunction
- Post-labyrinthitis syndrome
Mechanism of Action:
Betahistine acts as a histamine H1 receptor agonist and H3 receptor antagonist. It increases blood flow in the inner ear and enhances vestibular compensation by promoting neurotransmitter release. This dual mechanism reduces pressure in the endolymphatic system, restoring normal balance and hearing.
Technical Specifications:
- Chemical Name: 2-(2-Pyridyl)ethylamine dihydrochloride
- Molecular Formula: C₈H₁₂Cl₂N₂
- Molecular Weight: 207.10 g/mol
- CAS Number: 5638-76-6
- Description: White or almost white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Melting Point: 147°C – 150°C
- Solubility: Freely soluble in water and methanol; slightly soluble in ethanol
- Storage Conditions: Store below 30°C in a tightly closed container, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Antivertigo / Vestibular Agent
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Tablets (8 mg, 16 mg, 24 mg)
- Capsules
- Oral suspensions
Quality & Manufacturing – Bluepill Express Standards:
- Manufactured in WHO-GMP, ISO, and cGMP-certified facilities
- High assay purity (≥99%) and low impurity content
- Verified using HPLC, IR, and UV analytical methods
- Batch-to-batch uniformity and stability ensured
- Pharmacopeial-grade compliance with COA, MSDS, and DMF available
- Controlled manufacturing environment for purity and performance
Advantages of Bluepill Express Betahistine Dihydrochloride API:
- Consistent purity and stability ideal for solid dosage formulations
- DMF-ready API suitable for regulated market submissions
- Regulatory support documents for export and registration
- Pharma-grade crystalline structure ensuring excellent solubility
- Trusted export supply chain with timely and flexible logistics
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with LDPE liner
- Shelf Life: 36 months under recommended storage
- Labeling: As per international pharmacopeial and export requirements
- Export Markets: Europe, Asia-Pacific, Africa, Middle East, South America
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF – on request)
- Stability and impurity profile data
