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Berberine

CAS 633-65-8

Berberine Hydrochloride Powder

Name: Berberine Hydrochloride Powder
Brand: PathGene

Purity≥97.0%

Berberine salt for botanical and nutrition formulation development

Berberine hydrochloride (berberine HCl, CAS 633-65-8) is supplied as crystalline powder with a ≥97.0% purity specification. It is distinct from dihydroberberine (DHB). Batch COA and evaluation samples support raw-material qualification; MOQ 1 kg, with 1 kg, 5 kg and 25 kg packs. nutrition & functional ingredients

Quote / sample & delivery

MW371.82 g/mol

Berberine Hydrochloride Powder (CAS 633-65-8) bulk active ingredient

Key Specifications

Product Positioning	Berberine salt for botanical and nutrition formulation development
Application Scenarios	botanical active research · nutrition capsule formulas · aqueous salt-formulation screening
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

Procurement & delivery

Supply details confirmed by intended use, volume and target market

Purity ≥97.0%CAS 633-65-8

MOQ1 kg

Lead Time3–5 business days

Packaging1 kg / 5 kg / 25 kg

Free sample available

View quality documents ↓

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. Berberine HCl and berberine chloride are names used for this berberine salt. It is a different ingredient from dihydroberberine (DHB, CAS 483-15-8); their specifications and batch documents are not interchangeable.

Other Names

Berberine chlorideBerberine HClBerberine chloride hydrateUmbellatine hydrochlorideNatural Yellow 185,6-Dihydro-9,10-dimethoxybenzo[g]-1,3-benzodioxolo[5,6-a]quinolizinium chlorideNSC 2260CAS 633-65-8

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.

Recent batch test data

Test items, specifications and results for the listed batch are shown here. View or request a COA in the quality documents section.

Batch No.

PGBH-260416

Test date

2026-04-17

Specification

In-house

Pack size

25kg/carton

Storage

Room temperature, protect from light

Conclusion

Conforms

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

View an available COA in the quality documents section. Check the document for its product form and batch; request a signed COA for your purchasing or shipment batch separately.

Applicable Dosage Forms

Hard capsules

Powder and functional beverage formulation

Powders

Softgels

Tablets

Sublingual tablets

Oral dissolving films

Berberine hydrochloride development essentials

Separate hydrochloride-salt mass from berberine-moiety mass; pharmaceutical and nutrition projects require their own ingredient and finished-product criteria.

97.6%

Assay (Berberine HCl, HPLC)

PGBH-260416 · Results apply to this lot; interpret purity, assay and water on their respective bases.

Composition candidates:: Compare microcrystalline cellulose or mannitol capsule fillers; screen tablet disintegrants and assess fill mass and unit size for fibre combinations.
Processing priorities:: Use a premix and staged scale-up for the coloured powder, controlling carry-over; chemical stability cannot establish probiotic survival.
Testing priorities:: Assay, content uniformity, tablet disintegration/dissolution, colour migration and packaged stability; test viable counts independently.

Review lot COA ↗Explore formulation and combination research ↓

Berberine hydrochloride formulation development: composition, processing and validation

Composition candidates, processing sequences and tests support pilot design. Confirm candidate excipients and processes using this material in the actual finished formulation.

Solid formats: carriers, loading and mixing

Define loading by ingredient mass, salt mass or active moiety. Use m = target mass / assay as supplied only when both share the same basis; convert dried-basis assays using water where appropriate, and do not substitute HPLC area purity for mass assay. Set excipient amounts from fill mass, bulk density and uniformity trials.
Compare microcrystalline cellulose or mannitol capsule fillers; screen tablet disintegrants and assess fill mass and unit size for fibre combinations.
Record ingredient lots, actual component masses, loading bases and addition sequence, retaining blanks and single-ingredient controls for traceable changes.

Processing and formats: pilot batches through filling

Use a premix and staged scale-up for the coloured powder, controlling carry-over; chemical stability cannot establish probiotic survival.
Select blending/filling equipment for the actual format, recording size, bulk density, mixing time and fill mass; liquid or softgel routes need separate carrier, sedimentation and container/shell compatibility testing.

Validation and scale-up: tests, retained samples and packaging

Assay, content uniformity, tablet disintegration/dissolution, colour migration and packaged stability; test viable counts independently.
Sample upper/middle/lower positions and start/middle/end filling; compare with ingredients, process blanks and single-ingredient results, documenting deviations and corrections.
Include actual packaging, transport and intended storage in retained-sample plans; ingredient COAs and storage conditions do not establish a new finished-product shelf life.

Literature-informed combinations and development insights

Application examples follow the materials, formats and findings actually studied. Combination studies, single-ingredient studies, commercial precedents and development candidates are distinguished.

Combination application studies

Human combination application study

Berberine + Bifidobacterium: a study using separate formats

The combination informs roles and endpoints while separate tablets and probiotic capsules provide a split-format precedent.

Show research and formulation insights +

Combination / selection rationale: The combination informs roles and endpoints while separate tablets and probiotic capsules provide a split-format precedent.

Published evidence / source details: A 2021 trial randomized 300 people and analysed 297 over 16 treatment weeks. Berberine and combination arms improved selected glycemic measures versus placebo; HbA1c did not significantly differ between combination and berberine alone.

Development insights: The separate formats do not demonstrate co-capsule stability. Start with separate packs, then test late blending; qualify the supplied salt and measure chemical assay, bacterial identity and viability independently.

Evidence scope: A specified berberine tablet and B. adolescentis preparation were studied, not all strains or automatically this supplied salt.

2021 · Ming et al. · DOI 10.1186/s13073-021-00942-7 ↗

Formulation development candidates

Formulation development candidate

Berberine HCl + fibre: colour, loading and assay recovery

Fibre changes loading, viscosity and analytical extraction, requiring finished-blend testing rather than ingredient assay alone.

Show research and formulation insights +

Combination / selection rationale: Fibre changes loading, viscosity and analytical extraction, requiring finished-blend testing rather than ingredient assay alone.

Published evidence / source details: The berberine/Bifidobacterium study did not validate an arbitrary fibre blend; it provides related context, not blend efficacy.

Development insights: Screen soluble and insoluble fibres, checking assay recovery, uniformity, caking and colour transfer. Measure viscosity, settling and bitterness; compare capsules with separate fibre sachets.

Evidence scope: Formulation-screening guidance, not a validated fibre-combination trial.

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.

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.

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 are the MOQ and pack options for berberine hydrochloride powder?+

The raw-material MOQ for berberine hydrochloride powder is 1 kg, with pack options of 1 kg, 5 kg, 25 kg. Typical lead time is 3–5 business days, with dispatch confirmed for the order.

Does berberine and probiotic research validate a combined capsule?+

Not by itself. A published study used berberine tablets and Bifidobacterium capsules as separate products. A combined-capsule project needs its own chemical-assay and viable-cell tests, including processing and end-of-storage performance. Qualify the bacterial preparation and the supplied berberine salt rather than assuming all probiotic strains or berberine forms are equivalent.

Why Choose PathGene

Direct China manufacturer supply — factory pricing, no middleman
Recent-batch COA & batch traceability
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 testing support available on request

Documents Available

·Product specification sheet — request from sales
·Recent-batch COA — confirm by product and batch
·Other quality documents — confirm by product and batch

Documents are subject to product and batch availability; third-party reports are provided only when applicable.

Quality documents

Review specifications first, then batch data at shipment

The specification sheet defines acceptance limits. The COA shows actual batch results, which may vary by batch. Third-party reports are provided only for products or batches that have been independently tested.

Product specification

Stable acceptance criteria · Available on request

Recent-batch COA

Actual test data · Check the COA for the applicable batch

View COA online

Technical Resources

Berberine Technical Articles

View all articles →

Dihydroberberine vs Berberine HCl: Evidence and Bulk Ingredient Comparison

Dihydroberberine and berberine hydrochloride are different materials. Compare chemical identity, quality documents and formulation testing before using pharmacokinetic research to guide a purchase.

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Interested in Berberine?

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What Is Berberine?

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.

Why Choose PathGene

Direct China manufacturer supply — factory pricing, no middleman

Recent-batch COA & batch traceability

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

Berberine Hydrochloride Powder

What Is Berberine?

Other Names