Nicotine dependence is a major challenge to global public health - data from the World Health Organization show that 60% of smokers who quit smoke experience severe withdrawal symptoms in the first week, resulting in an annual relapse rate of over 80%. Faced with this stubborn pain point, the pharmaceutical industry is in urgent need of clinically proven solutions.
Cytisine, a natural alkaloid derived from the traditional Eastern European medicinal plant (Thermopsis lanceolata/Sophora alopecuroides), has been proven to be an effective smoking cessation active ingredient in more than 50 years of clinical applications due to its mechanism of action of selective binding to nicotine receptors. As a core raw material supplier in this field, KINTAIBIO® produces 98% high-purity cytisine powder, which provides key formula raw materials for global smoking cessation product developers.


The smoking cessation efficacy of cytisine is based on rigorous scientific evidence: a study in the New England Journal of Medicine pointed out that its efficacy is comparable to that of varenicline, but the cost is only 1/10. Through innovative extraction technology, KINTAIBIO® purifies 98% Sparteine powder that meets pharmaceutical standards. Its molecular structure is clear (CAS 485-35-8) , providing pharmaceutical companies with traceable and scalable core raw materials.

In response to the core needs of B-end customers for raw material purity, compliance and supply chain reliability, kINTAIBIO® 98% cytisine powder has achieved:
- Compliance guarantee: GMP-certified production, COA, and related research reports
- Mass production capacity: annual production capacity ≥100kg, supporting seamless supply from clinical stage to commercialization
- Global applicability: in line with ICH stability guidelines (24 months at 40°C/RH75%)
This article will conduct an in-depth analysis of cytisine's mechanism of action, global market status, clinical data and key indicators of raw material procurement (purity, residual solvents, heavy metal limits, etc.), to help you efficiently develop a new generation of smoking cessation therapies. If you want to buy the raw material of 98% Sparteine powder directly, you can contact us at sales@kintaibio.com.
Kintaibio® 98% cytisine powder Products Description
Our Sophora Alopecuroides Extract Cytisine powder (CAS 485-35-8) is a natural alkaloid extracted from the leguminous plant Sophora alopecuroides. As a partial agonist of the α4β2 nicotinic acetylcholine receptor (nAChR), it relieves withdrawal symptoms by activating the receptor at low intensity (agonism) and competitively blocks the binding of nicotine to the receptor (antagonism). This dual mechanism is different from the NRT therapy that only provides nicotine replacement.

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KINTAIBIO® 98% high-purity cytisine powder (HPLC determination) we provide can ensure:
- The difference between batches of receptor binding activity is ≤5%, ensuring the consistency of the dosage of the end product;
- The impurity content is <0.5%, meeting the control requirements of ICH Q3A for unknown impurities;
- The heavy metal residues (Pb/Cd/As/Hg) meet the USP<232> standard, reducing the complexity of the safety risk assessment of the end product.
Global application and regulatory progress of cytisine
Cytisine Powder, as an active ingredient for smoking cessation, has been used in mature products in many countries.This ingredient has supported mature smoking cessation brands in the Eastern European market for decades (such as Tabex® and Desmoxan®), serving more than 20 million smokers.
- Tabex® (Bulgaria): Sopharma has been on the market since 1964, with a 25-day reduction regimen, covering the OTC market in Central and Eastern Europe.
- Desmoxan® (Germany): Prescription preparation, using a decreasing dosage regimen similar to Tabex.
- Citizin® (Russia): A localized brand, with dosage forms including tablets and solutions.
Note: The above brands are independently operated by third parties and are only examples of ingredient application, not commercial recommendations.

Key clinical evidence (supporting cytisine effectiveness)
- Traditional smoking cessation: The Cochrane systematic review (involving 8,000+ subjects) showed that the 6-month smoking cessation success rate of cytisine was significantly better than that of placebo (RR=3.98, 95%CI 2.01-7.87).
- E-cigarette cessation: ORCA-V1 Phase II trial (JAMA Internal Medicine, 2024): The cytisinicline group had a cessation rate of 32.1% vs. 15.0% in the placebo group (p=0.002).
- FDA regulatory breakthroughs and market opportunities in July 2024: Based on the ORCA-V1 data, the FDA granted cytisinicline for e-cigarette cessation, accelerating its approval process in the United States.
- Phase III trial progress:
Achieve Life Sciences has completed the ORCA-2/ORCA-3 trials (smoker indications), and the NDA was submitted in June 2025; ORCA-V2 (e-cigarette indications) Phase III is in progress.
Potential market growth:
If approved, the United States will become the world's first market to approve cytisinicline for dual cessation of e-cigarettes and traditional cigarettes, creating new incremental demand.
kintaibio® parameters of 98% cytisine powder
Purity and Consistency Industrial Assurance
| Parameter | Standard | Testing Method | Customer Value |
|---|---|---|---|
| Active Ingredient Purity | ≥98.0% (HPLC-UV) | USP<621> | Bioavailability RSD ≤3% |
| Impurity Limit | ≤0.10% | ICH Q3A | Reduces the cost of impurity profile studies for end products |
| Batch-to-Batch Variation | ±0.3% (3-year stability data) | Accelerated Test (40°C / RH75%, 6 months) | Ensures uniformity of large-scale production doses |
Comprehensive Quality Compliance Documents
Basic Documents: COA provided for each batch (including HPLC spectrum, heavy metals, residual solvent data) and HPLC REPORT
Safety Reports: MSDS,TDS

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Multi-Industry Application Compatibility
| Application Area | Compliance Suggestion | Typical Dosage Form Reference |
|---|---|---|
| Pharmaceutical Formulations | Meets EP10.0/USP-NF standards | Coated tablets (1.5mg/tablet, generic Tabex®) |
| Dietary Supplements | Complies with FDA 21 CFR 111 | Plant capsules (with natural extract claims) |
Supply Chain Reliability Verification
- Production Capacity: Annual production ≥500KG (expandable to 2 tons), MOQ 1kg
- Delivery Capability: Standard Orders: Delivered within 30 days (global)
- Emergency Supply: 5% production capacity reserved for buffer, supporting expedited orders
- Export Experience: 120 batches of raw materials exported to the EU/North America in the past 3 years, with 0 customs detainment records
Where to Buy Cytisine 98% Powder: Your Purchasing Guide
The 98% cytisine powder produced by KINTAIBIO® is only available to compliant corporate customers, including qualified pharmaceutical factories, dietary supplement manufacturers, research institutions and licensed pharmaceutical traders (with API import and export licenses). According to China's "Drug Administration Law" and international psychotropic drug control regulations, this product is not sold to individual consumers.

Standardized procurement process
- Inquiry: Submit company information, use statement and target market through the official website form or sales@kintaibio.com
Order confirmation
- Specifications: 98% HPLC purity (EP10.0/USP-NF standard)
- Packaging: 25kg/food grade fiber barrel
- Price: CIF/FOB weekly floating quotation
- Quality agreement: COA (including HPLC spectrum, heavy metals, microbiological data) is attached to each batch, and SGS/BV third-party review is supported.








