Berberine
Berberine Hydrochloride
Key Specifications
| CAS Number | 633-65-8 |
| Purity | ≥97.0% |
| Molecular Formula | C₂₀H₁₈ClNO₄ |
| Molecular Weight | 371.82 g/mol |
| Appearance | Yellow crystalline powder |
| Solubility | Slightly soluble in water; soluble in hot water |
| Storage | Room temperature, protect from light |
| Shelf Life | 36 months |
CAS 633-65-8
What Is Berberine?
Berberine hydrochloride (CAS 633-65-8, C20H18ClNO4, MW 371.82 g/mol) is the hydrochloride salt of berberine, a quaternary isoquinoline alkaloid naturally occurring in the roots, rhizomes and bark of plants such as Coptis chinensis (Chinese goldthread), Phellodendron amurense (Amur cork tree), Berberis species and Hydrastis canadensis (goldenseal). It presents as a yellow crystalline powder and is one of the most widely used botanical alkaloids in the nutraceutical and pharmaceutical API markets. At commercial scale, berberine hydrochloride is not chemically synthesized from petrochemical feedstocks; instead it is produced by extracting the alkaloid-rich plant raw material with aqueous or ethanol-based solvents, followed by acid-base purification, concentration, salt formation with hydrochloric acid, and recrystallization to reach pharmaceutical- or food-grade purity.
Other Names
Key Features
High, Consistently Verified Purity
Each batch is assayed by HPLC to confirm purity of ≥97.0%, meeting the requirements for pharmaceutical API and high-grade dietary supplement applications.
Controlled Botanical Raw Material Sourcing
Raw plant material (primarily Coptis chinensis rhizome) is sourced from qualified, traceable suppliers and identity-tested before extraction to ensure consistent alkaloid content batch after batch.
Uniform Crystalline Appearance
Supplied as a free-flowing yellow crystalline powder with controlled particle size, suitable for direct compression, encapsulation or further formulation.
Comprehensive Contaminant Screening
Every lot is screened for heavy metals (Pb, As, Hg, Cd), residual solvents and microbial limits, with full certificates of analysis available on request.
Flexible Bulk & OEM Supply
Available in flexible bulk packaging (1kg to 25kg drums) with OEM/private-label formulation, custom particle size and documentation support for global B2B buyers.
| Molecular Formula | C₂₀H₁₈ClNO₄ |
| Molecular Weight | 371.82 g/mol |
| Appearance | Yellow crystalline powder |
| Solubility | Slightly soluble in water; soluble in hot water |
| Storage Condition | Room temperature, protect from light |
| Shelf Life | 36 months |
| Grade 1 | Pharmaceutical Grade · ≥97.0% · CP |
| Grade 2 | Food Grade · ≥95.0% · Food Safety |
End-Product Applications
Mechanism & Benefits
Anti-microbial and anti-inflammatory. Regulates gut microbiome, supports blood glucose management.
Packaging Options
1 kg 5 kg 25 kg
Lead Time
3–5 business days
Minimum Order
1 kg
Custom Packaging
Custom packaging (foil bags, HDPE drums), GMP labeling, and export documentation are available. Contact us for specifics.Certifications
CP
Chinese Pharmacopoeia
ISO
ISO
ISO9001
ISO 9001
Manufacturing Process
Raw Material Selection & Identity Testing
Qualified Coptis chinensis rhizome (or other berberine-rich botanical raw material) is sourced, identity-verified and pre-assayed for alkaloid content before being released to production.
Crushing & Pretreatment
The dried plant material is crushed to a suitable particle size to increase surface area and improve extraction efficiency in the subsequent solvent extraction step.
Solvent Extraction
The crushed material is extracted with acidified water or ethanol under controlled temperature and time to dissolve out the total alkaloid fraction, including berberine.
Acid-Base Purification
The crude extract undergoes acid-base treatment (and, where applicable, ion-exchange or resin adsorption) to remove pigments, polysaccharides, proteins and other co-extracted impurities, concentrating the berberine fraction.
Concentration & Salt Formation
The purified alkaloid solution is concentrated under reduced pressure and treated with hydrochloric acid to convert berberine into its more stable, crystalline hydrochloride salt form.
Crystallization & Recrystallization
Berberine hydrochloride is crystallized out under controlled cooling conditions, and recrystallized as needed to remove residual impurities and achieve the target purity of ≥97.0%.
Filtration, Washing & Drying
The crystals are separated by filtration, washed to remove mother liquor residues, and dried under controlled temperature to obtain a stable, low-moisture powder.
Milling, QC Testing & Packaging
The dried crystals are milled/sieved to the target particle size, sampled for full quality control testing (assay, appearance, heavy metals, microbial limits), and packed under moisture-protected conditions.
Quality Specifications
| Test Item | Specification | Result |
|---|---|---|
| Appearance | Yellow crystalline powder | Conforms, yellow crystalline powder |
| Odor | Odorless or faint characteristic odor | Conforms |
| Identification | Positive by UV/HPLC characteristic retention time | Conforms |
| Assay (Berberine HCl, HPLC) | ≥97.0% | 97.6% |
| Particle Size | 100% pass 80 mesh (or as customer-specified) | 98.5% pass 80 mesh |
| Loss on Drying | ≤5.0% | 2.8% |
| Residue on Ignition (Sulfated Ash) | ≤0.5% | 0.2% |
| Heavy Metals (Pb) | ≤10 mg/kg | <5 mg/kg |
| Arsenic (As) | ≤2 mg/kg | <1 mg/kg |
| Mercury (Hg) | ≤1 mg/kg | <0.5 mg/kg |
| Cadmium (Cd) | ≤1 mg/kg | <0.5 mg/kg |
| Total Plate Count | ≤1000 CFU/g | <500 CFU/g |
| Yeast & Mold | ≤100 CFU/g | <50 CFU/g |
| E. coli / Salmonella | Negative | Negative |
Purity & Assay Method
Purity is determined by high-performance liquid chromatography (HPLC) against a reference standard, in line with pharmacopoeial methods commonly used for berberine hydrochloride. Buyers should request the batch-specific certificate of analysis (COA) confirming the HPLC assay method, reference standard traceability, and acceptance criteria (≥97.0%) before finalizing purchase, and are welcome to arrange independent third-party verification.
Solubility & Formulation
Berberine hydrochloride is slightly soluble in cold water but soluble in hot water, and only sparingly soluble in ethanol, which should be factored into formulation and process design. For oral solid dosage forms (tablets, capsules), standard direct-blend or wet-granulation techniques are typically suitable; for liquid or beverage applications, gentle heating, micronization, or the use of solubilizers/carrier systems (e.g., cyclodextrins, phospholipid complexes) can help improve dispersibility. Customers developing new formats are encouraged to request a small sample for compatibility and dissolution trials before scale-up.
Available Product Forms
Bulk Berberine Powder
High-purity raw powder for supplement factories, research organizations, ingredient distributors, and contract manufacturers.
Berberine Capsules
Custom capsule strength, shell material, bottle count, excipients, and label design for private-label brands.
Berberine Tablets
Tablet formulation, granulation, compression, coating, bottle packaging, and custom labeling support.
Berberine Powder Blends
Berberine can be blended with complementary actives (antioxidants, other longevity ingredients, vitamins, minerals) per customer formula.
How is the purity of your berberine hydrochloride confirmed?+
Every batch is tested by HPLC against a certified reference standard, and a full certificate of analysis (COA) with the purity result, appearance, heavy metals and microbial data is provided with each shipment.
What raw material and production method do you use?+
Our berberine hydrochloride is produced from qualified, identity-verified plant raw material (primarily Coptis chinensis rhizome) through solvent extraction, acid-base purification, salt formation with hydrochloric acid, and recrystallization — not petrochemical chemical synthesis.
How soluble is berberine hydrochloride, and does that affect formulation?+
It is slightly soluble in water at room temperature but more soluble in hot water, and only sparingly soluble in ethanol. This should be considered when designing tablets, capsules, or liquid formats, and we can advise on suitable approaches based on your intended application.
Can I request a sample before placing a bulk order?+
Yes, small free or low-cost samples are available for quality evaluation, dissolution testing, or formulation trials prior to committing to a bulk purchase order.
Do you support independent third-party testing?+
Yes, in addition to our internal COA for every batch, we support and cooperate with independent third-party laboratory testing requested by customers for purity, contaminants, or other specifications.
Do you offer OEM or private-label services?+
Yes, we offer OEM/private-label supply including custom particle size, custom blends, and customer-branded packaging and labeling for finished dietary supplement or API customers.
What packaging options are available?+
Standard packaging includes moisture-protected drums or bags in 1kg, 5kg, and 25kg formats, with custom packaging sizes and materials available on request for larger orders.
What is the MOQ and how do I get a quotation?+
MOQ varies by packaging format and application; please contact our sales team with your target volume, purity requirement, and destination country to receive a detailed quotation and lead time.
Why Choose PathGene
- Direct China manufacturer supply — factory pricing, no middleman
- Batch-specific COA & full traceability on every shipment
- In-house R&D + synthetic biology / enzymatic production platform
- Free sample for qualified B2B buyers before commercial order
- Flexible MOQ — from lab-scale trial to ton-scale commercial supply
- One-stop OEM/private-label support for finished dosage forms
- Worldwide shipping by courier, air freight, and sea freight
OEM & Private-Label Services
- ·Custom capsule manufacturing
- ·Custom tablet manufacturing
- ·Powder blending & custom formulation
- ·Private-label bottles, pouches & labels
- ·Small trial orders
- ·Bulk commercial production
- ·Export documentation
- ·Third-party laboratory testing
Documents Available
- ·Certificate of Analysis (COA)
- ·Product specification sheet
- ·Material Safety Data Sheet (MSDS)
- ·Manufacturing flow chart
- ·HPLC test report
- ·Heavy-metal test report
- ·Microbiological test report
- ·Non-GMO / allergen statement
- ·Country-of-origin documentation
- ·Packing list & commercial invoice
Certificate availability should be confirmed with our sales team before ordering.
Sample Certificate of Analysis
PathGene Biotech Co., Ltd.
南京派琪生物科技有限公司
CERTIFICATE OF ANALYSIS
Layout example — not an issued batch record
Product Name
Berberine
CAS No.
633-65-8
Batch No.
PG-SAMPLE-000000
Packaging
Issued upon order confirmation
| Test Item | Specification | Result |
|---|---|---|
| Appearance | Yellow crystalline powder | Conforms, yellow crystalline powder |
| Odor | Odorless or faint characteristic odor | Conforms |
| Identification | Positive by UV/HPLC characteristic retention time | Conforms |
| Assay (Berberine HCl, HPLC) | ≥97.0% | 97.6% |
| Particle Size | 100% pass 80 mesh (or as customer-specified) | 98.5% pass 80 mesh |
| Loss on Drying | ≤5.0% | 2.8% |
| Residue on Ignition (Sulfated Ash) | ≤0.5% | 0.2% |
| Heavy Metals (Pb) | ≤10 mg/kg | <5 mg/kg |
| Arsenic (As) | ≤2 mg/kg | <1 mg/kg |
| Mercury (Hg) | ≤1 mg/kg | <0.5 mg/kg |
| Cadmium (Cd) | ≤1 mg/kg | <0.5 mg/kg |
| Total Plate Count | ≤1000 CFU/g | <500 CFU/g |
| Yeast & Mold | ≤100 CFU/g | <50 CFU/g |
| E. coli / Salmonella | Negative | Negative |
Conclusion: Conforms to internal quality specifications
The COA issued with your order will carry the actual batch number, manufacture/test dates, and QC signature.
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