Cytisine

The purity of our Cytisine is as high as 98%, making it a pharmaceutical grade product. At the same time, we can also produce cytisine that meets the requirements of cosmetics, health products, and other grades. If you would like to learn more information about it, you can contact us via sales@jayuanbio.com and sales1@jayuanbio.com at any time if you feel free. We will serve you wholeheartedly.

Specifications

Application Areas

(1) Smoking cessation medication：Cytisine is a partial agonist of nicotine receptors, which can alleviate withdrawal symptoms during smoking cessation and reduce cravings for nicotine. Its effect is similar to Champix, but at a lower cost. In Eastern Europe (such as Poland and Russia), it has been used as a smoking cessation medication for decades, with product names including Tabex ®、 Desmoxan ® Wait. Its raw materials come from natural plants, resulting in fewer side effects (which may include dry mouth, nausea, etc.), and the treatment course is usually 25-30 days.

(2) Neuroscience research：It can be used to study the mechanism of action of nicotine receptors and explore therapeutic targets for addictive diseases. And as a structural template, design new drugs for smoking cessation or neurodegenerative diseases.

(3) Agricultural use: Plantagene has insecticidal activity and has been used for pest control in organic agriculture, but its widespread application is limited by its toxicity to mammals.

(4) Traditional Medicine：Some traditional medical systems (such as Eastern Europe and Central Asia) were once used for respiratory diseases (such as bronchitis and asthma), but they are now less commonly used due to toxicity risks.

COA

Production process flow

This is our prodution process of Cytisine. This process ensures the stability of product quality and solvent residue below international standards from raw materials to purification.

Quality Inspection Document

Certificates

At Jayuan, we take pride in our commitment to quality and safety. Our product is manufactured in accordance with the highest industry standards and is certified by reputable organizations including FSSC22000, ISO22000, HALAL, KOSHER, and HACCP.

Patents

Jayuan has been deeply involved in the raw material medicine and plant extract industries for over 20 years, with a first-class R&D team and advanced equipment. We have obtained multiple patents.

Research and Development
Xi'an Jayuan Bio currently has over 80 employees and a professional R&D team of 30 people. Specializing in the research and testing of plant active ingredients, continuously improving and innovating extraction processes, standardized production processes, and a strong quality control management system, effectively ensuring the stability and bioavailability of product quality.

Packaging and Transportation

For pharmaceutical-grade products, cold chain transportation (2-8°C) is used, using ice packs or refrigerated trucks. For room-temperature transportation, use a light-blocking box and insulation materials to avoid direct sunlight. This effectively protects product quality and stability. With direct global access by sea, land, and air, our professional logistics team ensures on-time delivery, covering the European, American, and Southeast Asian markets

Exhibitions

Jayuan has participated in industry exhibitions such as CPHI, API, PMEC, and Vitafoods Asia for many years, showcasing its core products and latest technological advancements for in-depth discussions and collaborations with pharmaceutical companies, research institutions, and industry experts from around the world. Through these exhibitions, Xi'an Jayuan Bio aims to showcase its technological strengths and product advantages, expand domestic and international markets, seek more partnership opportunities, and contribute to the development of the global pharmaceutical industry.

If you are interested in our products or would like to discuss collaboration, please contact us immediately. We will be happy to serve you. We believe Jayuan will bring you a unique experience and surprises.

Looking forward to your feedback!

Payment

In order to meet the payment needs of different customers, we offer a variety of flexible, secure, and global payment methods, covering traditional bank transfers, modern digital payments, and customized solutions.

After-sales Service

Our responsive support team provides expert technical assistance and guidance to ensure smooth product integration.

Production Workshop

Our workshop complies with GMP standards and meets Class D cleanroom standards. Use corrosion-resistant materials such as stainless steel 316L to ensure workshop safety regulations.

Why choose us?

1. Full Supply Chain Control: We own a 50,000-square-meter natural cytisine cultivation base, equipped with advanced airflow milling equipment to ensure uniform, contamination-free product particles, achieve ultra-fineness control, and effectively enhance bioavailability. Low-temperature milling technology is used throughout the production process to effectively protect the plant's active ingredients. Intelligent production, with real-time monitoring of feed rates, ensures batch-to-batch product stability. Heavy metal and solvent residues are below international limits. Our integrated approach, from raw material cultivation to extraction and purification, reduces intermediate steps and ensures full traceability throughout the production process. This ensures a stable, cost-effective supply and supports large-volume order fulfillment, helping customers maximize profits.

2. Standardized production process: First, preferably gorse seeds are crushed to 60-80 mesh to increase the effective contact area. They are then treated with ammonia or sodium hydroxide (pH 9-10) to release the alkaloids from the plant cells. Next, they are soaked in dilute hydrochloric acid (pH 2-3) to dissolve the cytisine salt in water. The pH is then adjusted to 9-10 to precipitate the cytisine. Finally, extraction is performed with chloroform or dichloromethane, followed by concentration and recrystallization (ethanol-water system). Purity is then determined using preparative HPLC.

3. Tertiary Purification: In the first step, macroporous resin enrichment is used to effectively remove impurities such as pigments and polysaccharides from plant extracts, significantly improving the purity of the target component. HPD-600 weakly polar resin is soaked in 95% ethanol for 24 hours to allow for full swelling. The resin is then rinsed with ethanol until the effluent is colorless (to remove residual porogen). The resin is then rinsed sequentially with 5% HCl, 5% NaOH, and distilled water until neutral. The crude plant extract is then dissolved in dilute hydrochloric acid (pH 2-3), filtered to remove insoluble matter, and the pH is adjusted to 6-7 to prevent strong acid damage to the resin structure. Using 10-20 mg of cytisine/mL of extract at a flow rate of 1-2 BV/h (column volume/hour), dynamic adsorption rates exceeding 90% are achieved. Water-soluble impurities such as sugars and inorganic salts are then washed with 3-5 BV of distilled water. Weakly polar impurities (such as some flavonoids) are then eluted with 10% ethanol. Then adsorb with 50-70% ethanol solution, with an elution volume of 3-5 BV, and collect in sections (each tube is tested by HPLC).

The second step is silica gel column chromatography, which is low-cost and has a high sample loading capacity. It is suitable for removing structural analogs and effectively separates structural analogs (such as N-methylcytisine) from polar impurities. Use 200-300 mesh silica gel (such as Merck Silica Gel 60), bake at 105°C for 2 hours, and store sealed. Wet pack the column (using a 9:1 chloroform-methanol mixture for homogenization) with a height-to-diameter ratio of 15:1 (e.g., 30 x 2 cm). Dissolve 100-200 mg of the crude product (50-70% purity) in a minimal amount of elution solvent (e.g., 9:1 chloroform-methanol mixture). Add 1-2 g of silica gel and mix the sample. Evaporate the solvent. Evenly spread the sample-mixed silica gel on the top of the column and cover with a layer of quartz sand to prevent disturbance. Chloroform-methanol-ammonia (90:9:1, v/v/v) is used. The ammonia is used to adjust the pH to alkaline to minimize cytisine tailing. The flow rate is controlled at 1-2 mL/min (manual pressurization or low-pressure chromatography system). Collect fractions (5-10 mL per tube) and monitor in real time using TLC or HPLC. TLC conditions: silica gel GF254 plates, developing solvent (chloroform-methanol-ammonia = 8:2:0.2), cytisine Rf ≈ 0.4 at 254 nm. HPLC conditions: C18 column, acetonitrile-0.1% phosphoric acid (15:85), detection at 265 nm.

The third step, preparative HPLC, is the core technology for obtaining high-purity cytisine (≥98%), particularly suitable for preparing pharmaceutical-grade standards or reference materials. First, the crude product (80-90% purity) is dissolved in methanol and filtered through a 0.22 μm filter to prevent particulate clogging of the column. The concentration is controlled between 50-100 mg/mL (higher concentrations will result in peak broadening). Next, using an analytical column (4.6 × 150 mm), the gradient is optimized by testing different B-phase ratios (e.g., 15% to 35% acetonitrile) and selecting baseline separation conditions. The resolution between the main peak and the nearest impurity peak is measured (Rs ≥ 1.5). After sample loading, the gradient program is initiated, with the UV detector monitoring the signal at 265 nm. The main peak is automatically collected (retention time ±0.5 min) to avoid impurities. The target fractions are then combined and evaporated under reduced pressure at 40°C to remove the acetonitrile. Finally, a white powder is lyophilized (dialysis is required for desalting when containing an aqueous buffer) or recrystallized from ethanol and water (7:3) to further improve purity. HPLC-UV analysis was performed using a C18 column, acetonitrile-water (15:85), and detection at 265 nm. The main peak area was ≥98.0% (area normalized method), and the presence of a single impurity was <0.1%. Cytisine with a purity of 98% was obtained.

Step-by-step improvement effectively improved product purity and bioavailability.

4. Impurity Analysis and Control: Solvent residue is a key indicator affecting the safety of cytisine, especially for pharmaceutical use. It must comply with international pharmacopoeia standards such as ICH Q3C and EP/USP. For solvent residues, ethanol, ethyl acetate, and other residues are tested using GC (compliant with ICH Q3C). For heavy metal residues, atomic absorption spectroscopy (AAS) or ICP-MS is used to detect lead, arsenic, and other residues (≤10 ppm). For pesticide residues, GC-MS/LC-MS is used to screen for organochlorine and organophosphorus pesticides (compliant with EU MRLs). Heavy metal and solvent residues are strictly controlled to international pharmacopoeia standards (USP/EP), meeting the high-end demands of pharmaceuticals, health supplements, and cosmetics.

5. Comprehensive and Professional Test Reports: We operate five GMP-compliant production lines, rigorously controlling key indicators such as heavy metals and solvent residues throughout the production process. Our internal control standards exceed those of pharmacopoeias such as USP/EP. For example, HPLC main peak area ≥ 98% (excluding solvent peak) and single impurity ≤ 0.1% (HPLC normalization method). We also support third-party verification, with samples sent to SGS, Eurofins, and other agencies for review. We provide Certificates of Approval (COA), heavy metal test reports, and microbiological test reports. SGS reports are included with shipment, and we also support third-party testing. This ensures full traceability from raw materials to finished product, ensuring batch-to-batch quality consistency and cost advantages, helping customers maximize profits.

6. Professional Testing Equipment and Personnel: We have five complete GMP-compliant production lines, equipped with a dedicated testing laboratory and 20 professional testing personnel. From production base to workshops and testing personnel, we provide seamless integration throughout the entire process. We are equipped with advanced Agilent and Waters high-performance liquid chromatography (HPLC) equipment, Shimadzu gas chromatographs (GC), Shimadzu and PerkinElmer ultraviolet spectrophotometers (UV), and other equipment. We also have Agilent and Waters mass spectrometers for high-precision qualitative and quantitative analysis. These advanced testing instruments ensure the highest accuracy of product quality and purity.

7. Stability and Packaging and Storage: To ensure the chemical stability, purity, and safety of cytisine during storage and transportation, we implement systematic management across multiple aspects, including packaging material selection, environmental control, and stability verification.

In accelerated testing, cytisine is stored at 40°C ± 2°C/75% RH ± 5% for six months to simulate long-term stability. Products are considered acceptable if the purity decreases by ≤1% and the impurity increase by ≤0.2%. In long-term testing, cytisine is stored at 25°C ± 2°C/60% RH ± 5% for 36 months, with actual storage data supporting the expiration date. In forced degradation testing, degradation pathways are verified under extreme conditions, including light exposure (1.2 million lux·hr), high temperature (60°C), and oxidation (3% H₂O₂). Cytisine is packaged in nitrogen-filled, sealed aluminum foil composite bags to inhibit oxidation and can be stored at 2-8°C, protected from light, for 36 months (long-term testing).

8. Safe Transportation: For pharmaceutical-grade products, cold chain transportation (2-8°C) is used, using ice packs or refrigerated trucks. For room-temperature transportation, use a light-blocking box and insulation materials to avoid direct sunlight. This effectively protects product quality and stability. With direct global access by sea, land, and air, our professional logistics team ensures on-time delivery, covering the European, American, and Southeast Asian markets.

9. Strong Production Capacity: Our high-quality cytisine produces 3-5 tons per month, with tons of inventory in stock, ensuring timely delivery of large orders. We provide one-stop service from sample testing to bulk delivery.

10. Customized Solutions: We offer customized packaging solutions, such as OMD/OEM, supporting a variety of packaging specifications and formats to flexibly meet different customer needs.
11. Quality Control and Release Standards: Our products are highly pure and stable, with impurity control meeting EP/USP standards. We are ISO9001 and ISO2000 certified, and meet both food-grade and cosmetic-grade standards.

Contact Us

Ready to experience the superior quality of our Cytisine 98%? Contact our expert team as soon as possible, we're always here waiting for serving you.

Looking forward to your immediate feedback!

Your prompt email would be greatly appreciated!

Email: sales@jayuanbio.com sales1@jayuanbio.com

Address: Xi'an Hi-Tech Industrial Development Zone, Shaanxi Province, China