Berberine Hydrochloride
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Berberine Hydrochloride Powder​

Berberine Hydrochloride Powder

  1. English Name: Berberine Hydrochloride Powder
  1. Specification
    • Purity: ≥ 98% (HPLC)
    • Solubility: Sparingly soluble in water (0.12 g/100 mL at 25°C), more soluble in hot water; soluble in ethanol (≥ 5 g/100 mL)
    • Appearance – related: Loss on drying ≤ 1.0%, Heavy metals ≤ 10 ppm, Residual solvents ≤ 0.5%
    • Particle Size: ≤ 100 mesh (standard), can be customized according to requirements
  1. Appearance
    • Bright yellow crystalline powder, odorless, with an intensely bitter taste, no relation to chocolate in terms of color or aroma
  1. CAS NO.：633 – 65 – 8
  1. Lead time: 5 – 7 Working Days
  1. Package
    • 1 kg/aluminum foil bag, 25 kg/drum (double – layer PE bag inside cardboard drum)
  1. Main Market
    • Global market, with significant demand in Asia (China, India), Europe, and North America, mainly applied in pharmaceuticals, dietary supplements, veterinary medicine, and cosmetics industries
  1. Application Scenarios

Core Properties

  • Chemical Structure: An isoquinoline alkaloid with the molecular formula C₂₀H₁₈ClNO₄. Its unique heterocyclic structure endows it with multiple biological activities.
  • Key Features
    • Antimicrobial: Effective against a wide range of pathogens, including bacteria like Escherichia coli and Staphylococcus aureus, fungi such as Candida albicans, by disrupting cell membranes and inhibiting essential enzyme functions.
    • Antioxidant: Scavenges free radicals like hydroxyl and superoxide anions, protecting cells from oxidative damage and reducing the risk of aging – related diseases.
    • Anti – inflammatory: Suppresses the activation of inflammatory pathways, reducing the production of pro – inflammatory cytokines (TNF – α, IL – 6), which helps relieve inflammation – related symptoms.
    • Hypoglycemic: Regulates glucose metabolism by enhancing insulin sensitivity, inhibiting intestinal glucose absorption, and promoting cellular glucose uptake, making it useful for managing blood sugar.
    • Lipid – lowering: Reduces hepatic cholesterol synthesis and promotes cholesterol excretion, contributing to lower blood lipid levels.

Application Scenarios

1. Pharmaceutical Industry

  • Oral Medications:
    • Used in tablets, capsules, and oral solutions for treating gastrointestinal infections, diarrhea caused by bacteria, and as an adjuvant treatment for mild to moderate type 2 diabetes to regulate blood glucose.
  • Topical Formulations:
    • Incorporated into creams, ointments, and gels for treating skin infections, acne, and eczema, leveraging its antimicrobial and anti – inflammatory properties.
  • Clinical Research:
    • Under investigation for potential applications in treating cardiovascular diseases, neurodegenerative disorders, and certain cancers due to its broad – spectrum bioactivity.

2. Dietary Supplements

  • Health – Management Supplements:
    • Sold as standalone capsules or combined with other ingredients (e.g., gymnema sylvestre, chromium) to help individuals manage blood sugar, improve cardiovascular health, and boost immune function.

3. Veterinary Medicine

  • Animal Health Products:
    • Added to livestock and poultry feed or used in oral medications to treat digestive tract infections, diarrhea, and enteritis, and enhance animal growth performance.
  • Pet Care:
    • Prescribed for pets with bacterial infections, skin problems, or to support metabolic health in diabetic pets.

4. Cosmetics & Personal Care

  • Anti – Acne Products:
    • Added to facial cleansers, toners, and spot – treatment creams (0.5 – 2% concentration) to combat acne – causing bacteria, reduce inflammation, and prevent breakouts.
  • Anti – Aging Products:
    • Some high – end anti – aging serums and creams contain berberine hydrochloride to protect skin from oxidative stress and reduce the appearance of fine lines and wrinkles.

Detection Methods

  • High – Performance Liquid Chromatography (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% phosphoric acid (30:70, v/v), Flow Rate: 1.0 mL/min, Detection Wavelength: 345 nm, for accurate quantification.
  • Liquid Chromatography – Mass Spectrometry (LC – MS):
    • Ideal for analyzing berberine hydrochloride in complex samples, providing high sensitivity and the ability to detect trace amounts and identify impurities.
  • Fourier Transform Infrared Spectroscopy (FTIR):
    • Analyzes the characteristic absorption peaks of functional groups to confirm the chemical structure, aiding in quality control during production.

Source & Advantages

  • Natural & Synthetic Sources: Extracted from plants like Coptis chinensis, Berberis vulgaris, and can also be synthesized chemically, ensuring a stable supply.
  • Versatile Applications: Its multifunctional bioactivity makes it valuable across multiple industries, meeting diverse health and beauty needs.
  • Market Growth: With the rising demand for natural remedies and preventive healthcare products, the market for berberine hydrochloride powder continues to expand.
  • Regulatory Oversight: Recognized and regulated in many regions for use in pharmaceuticals, supplements, and cosmetics, though regulations on dosage and claims vary by country.
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Berberine Hydrochloride Powder: Ultimate Guide by Zhonghong BioTech

1. What is Berberine Hydrochloride?
Berberine Hydrochloride is the stabilized, bioavailable salt form of berberine, a potent isoquinoline alkaloid naturally occurring in plants like Berberis vulgaris (Barberry), Coptis chinensis (Goldthread), and Hydrastis canadensis (Goldenseal). This bright yellow crystalline powder is renowned for its broad-spectrum physiological activities, primarily targeting metabolic pathways via AMPK activation.

2. Source, Chemical Properties & Identification

  • Source: Extracted from plant rhizomes/roots (e.g., Coptis, Phellodendron). Zhonghong uses sustainably sourced, premium-grade Coptis chinensis.

  • Chemical Properties:

    • CAS: 633-65-8

    • Molecular Formula (MF): C₂₀H₁₈ClNO₄

    • Molecular Weight (MW): 371.81 g/mol

    • EINECS: 211-195-9

    • Appearance: Bright Yellow to Orange-Yellow Crystalline Powder

    • Solubility: Soluble in water, slightly soluble in ethanol, insoluble in non-polar solvents.

    • Melting Point: 200-203°C (decomposition)

    • Optical Rotation: -120° to -140° (c=2 in H₂O)

3. Premium Berberine HCl: Key Attributes (Zhonghong BioTech Standard)
Zhonghong BioTech sets the benchmark for pharmaceutical-grade Berberine HCl:

  • Composition: ≥98% Berberine Hydrochloride (HPLC), minimizing minor alkaloids (e.g., jatrorrhizine, palmatine).

  • Efficacy (Compliance): Manufactured under cGMP, compliant with USP/EP monographs. Validated for key bioactivities:

    • Metabolic Health: AMPK activation supporting healthy glucose uptake & lipid metabolism (PMID: 25607236).

    • Microbiome Modulation: Selective inhibition of pathogenic gut bacteria; promotes beneficial species.

    • Cardiovascular Support: Modulates LDL-receptor expression & endothelial function.

    • Cellular Health: Exhibits antioxidant and potential autophagy-enhancing properties.

  • Origin: Sourced & fully manufactured (extraction to micronization) in China, ISO 9001/22000 certified facilities.

  • Usage: Typical dose range: 500mg-1500mg daily, divided (e.g., 500mg TID). Formulated in capsules, tablets, or functional foods. Consult a healthcare provider.

  • Target Audience: Adults seeking metabolic/cardiovascular support. Not for children.

  • Crucial Precautions & Side Effects:

    • Contraindications: Pregnancy, lactation. Potent CYP3A4/P-gp inhibitor – avoid with cyclosporine, tacrolimus, simvastatin, many antibiotics. Consult physician if taking any medication.

    • Side Effects: Generally mild (dose-dependent): GI discomfort (constipation, cramping), rare potential for hypoglycemia.

    • Max Intake: Do not exceed 2000mg/day without medical supervision. Start low dose.

    • Testing: Recommend liver/kidney function monitoring with long-term, high-dose use.

4. Zhonghong BioTech: Pioneering Plant Actives Since 1996
Shaanxi Zhonghong Investment Technology Co., Ltd. is a vertically integrated leader in high-purity botanical extracts and bioactive compounds. We serve global innovators in nutraceuticals, pharmaceuticals, cosmeceuticals, and functional foods.

  • Scientific Edge: 5 University Joint Labs (e.g., CAS Institutes), 20+ Patents (e.g., Novel Purification, Polymorph Control), exclusive 10,000+ compound library.

  • Analytical Leadership: State-of-the-art QC: UHPLC-DAD-ELSD, GC-MS, ICP-MS, NMR. Purity standards exceed USP by ≥20% (typically ≥98.5% Berberine HCl).

  • Global Reach: cGMP-compliant supply to 80+ countries, offering bespoke solutions for Tier-1 Pharma and research institutions.

5. Health Benefits & Mechanisms

  • Glucose Homeostasis: Activates AMPK, enhances insulin sensitivity, inhibits hepatic gluconeogenesis (glucose-6-phosphatase), mimics insulin action.

  • Lipid Regulation: Upregulates hepatic LDLR expression, modulates PCSK9, activates AMPK→ACC inhibition.

  • Gut Health: Disrupts bacterial biofilm formation, inhibits virulence factors (e.g., E. coli LT/ST toxins), fosters Akkermansia/Bifidobacterium growth.

  • Cardioprotection: Improves endothelial NO synthesis, reduces LOX-1 expression, attenuates ox-LDL uptake.

  • Cellular Resilience: Modulates Nrf2/KEAP1 pathway, enhances endogenous antioxidants (SOD, GSH); potential mTOR inhibition influencing autophagy.

6. Usage Guidelines

  • Standard Dose: 500mg taken 2-3 times daily before meals. Bioavailability enhancers (e.g., liposomal, with piperine) may allow lower doses.

  • Formulation: Ideal for solid dosage forms (tablets, capsules). Ensure compatibility with excipients (hygroscopic).

  • Synergists: Often combined with Silymarin (liver support), Chromium Picolinate, or Alpha-Lipoic Acid.

7. Critical Precautions

  • Drug Interactions: STRONG CYP3A4/P-glycoprotein inhibition. Contraindicated with immunosuppressants, statins, most macrolides/fluoroquinolones, antifungals, SSRIs, Ca²⁺ channel blockers, sedatives. Mandatory HCP consultation if medicated.

  • Medical Conditions: Avoid in hypotension, bradycardia, renal/hepatic impairment. Monitor blood glucose closely in diabetics.

  • Duration: Limited long-term human safety data. Consider cycling (e.g., 8 weeks on, 2-4 weeks off).

8. Product Specification & Certificate of Analysis (COA)

Parameter Category Test Item Specification Test Method
Pesticide Residues Chlorpyrifos ≤ 0.01 ppm GC-MS/MS (EU 396/2005)
Cypermethrin ≤ 0.05 ppm GC-MS/MS (EU 396/2005)
Total DDTs ≤ 0.05 ppm GC-MS/MS (EU 396/2005)
Total BHCs ≤ 0.05 ppm GC-MS/MS (EU 396/2005)
Heavy Metals Lead (Pb) ≤ 1.0 mg/kg ICP-MS (USP <232>/<233>)
Arsenic (As) ≤ 1.0 mg/kg ICP-MS (USP <232>/<233>)
Cadmium (Cd) ≤ 0.5 mg/kg ICP-MS (USP <232>/<233>)
Mercury (Hg) ≤ 0.1 mg/kg ICP-MS/CVAAS (USP <232>/<233>)
Microbiological Total Aerobic Count ≤ 1000 CFU/g USP <61>
Yeast & Mold ≤ 100 CFU/g USP <61>
E. coli Absent in 1g USP <62>
Salmonella spp. Absent in 10g USP <62>
Staph. aureus Absent in 1g USP <62>
Assay (HPLC) Berberine Hydrochloride ≥ 98.0% USP Chromatographic

9. Advanced Production Flow

  1. Raw Material QC: Species authentication (HPTLC, DNA barcoding), heavy metal/pesticide screening.

  2. Extraction: Optimized acidified ethanol percolation (pH 2-3, 60°C).

  3. Macroporous Resin Purification: Selective adsorption/desorption to remove polysaccharides, pigments.

  4. Crystallization: pH-controlled anti-solvent crystallization (Ethanol/H₂O system) for defined particle size distribution.

  5. Recrystallization: High-purity solvent system for final polymorph control (Anhydrous form).

  6. Micronization: Jet milling to target D90 < 45µm for optimal dissolution.

  7. Strict QC: In-process checks & final release per COA specs. Stability studies (ICH Q1A).

10. Application Scenarios

  • Nutraceuticals: Metabolic health capsules, blood sugar support blends, weight management formulas.

  • Pharmaceuticals: API for anti-diabetic, anti-dyslipidemia, or antimicrobial formulations (research stage).

  • Functional Foods/Beverages: Fortified powders, health drinks (requires taste-masking).

  • Cosmeceuticals: Acne topical treatments (antibacterial/anti-inflammatory), anti-aging serums.

  • Research: Molecular biology (AMPK pathway studies), microbiology (antimicrobial mechanisms).

11. Stringent Quality Control
Zhonghong employs a multi-tiered QC strategy: Identity (FTIR, NMR fingerprinting), Assay (Validated RP-UHPLC with DAD/ELSD detection), Related Substances (HPLC for jatrorrhizine, palmatine <1.0%), Residual Solvents (GC-MS per ICH Q3C), Heavy Metals (ICP-MS), Microbiology (rapid methods & compendial), Particle Size (Laser diffraction), XRD (Polymorph verification). Our stability program (25°C/60% RH, 40°C/75% RH) ensures 36-month shelf life in alu-foil bags. Batch traceability is paramount.

12. Packaging & Logistics

  • Primary: Double HDPE bags with food-grade PE liner. Optional vacuum packing.

  • Secondary: Sealed in moisture-proof, light-resistant fiber drums (25kg net).

  • Logistics: Ambient shipping globally. MSDS, Certificate of Origin, Full COA provided. DDP/DAP terms available. Fast EU/US warehouse dispatch.

13. Research & Innovation

  • Health Mechanisms: Ongoing research explores NLRP3 inflammasome modulation, gut-brain axis impact, and mitochondrial biogenesis effects.

  • Tech Innovation: Zhonghong focuses on:

    • Enhanced Bioavailability: Novel nanoemulsions, phospholipid complexes.

    • Synthetic Biology: Engineered microbial biosynthesis of berberine precursors.

    • Derivatization: Novel berberine salts/esters for improved solubility/targeting.

  • Challenges: Overcoming low oral bioavailability (~<5%), managing DDIs, establishing definitive long-term clinical outcomes.

14. Frequently Asked Questions (FAQ)

  • Q: Is Berberine HCl better than Berberine Sulfate? A: HCl generally offers higher solubility and bioavailability than sulfate salts.

  • Q: Can I take Berberine HCl long-term? A: While generally safe for periods of 3-6 months in studies, discuss long-term use and cycling with your healthcare provider. Monitor liver/kidney function.

  • Q: Does it cause weight loss? A: It supports metabolic health and may aid weight management as part of a healthy lifestyle, primarily through AMPK effects on metabolism.

  • Q: How long to see benefits? A: Metabolic effects (glucose/lipids) often observed within 4-8 weeks.

  • Q: Is Zhonghong’s Berberine non-GMO & Allergen-Free? A: Yes, certified non-GMO, gluten-free, soy-free, dairy-free. Kosher/Halal available.

  • Q: Can I get a sample? A: Yes! Request below.

15. Sourcing & Samples
Source Premium Berberine Hydrochloride Powder:

Conclusion
Berberine Hydrochloride Powder represents a powerful tool in metabolic health support. Choosing a supplier with uncompromising quality, scientific rigor, and regulatory expertise like Zhonghong BioTech is critical for product efficacy and safety. Our vertically controlled process, from validated botanical sourcing to cutting-edge purification and QC, delivers berberine HCl of exceptional purity (>98%) and consistent biological activity. Contact us today to elevate your formulations.

References (Illustrative)

  1. Imenshahidi M, Hosseinzadeh H. Berberine and barberry (Berberis vulgaris): A clinical review. Phytother Res. 2019.

  2. Pang B, et al. Application of berberine on treating type 2 diabetes mellitus. Int J Endocrinol. 2015.

  3. Koppen LM, et al. Efficacy of berberine in cardiovascular disease risk reduction. Nutr Metab Cardiovasc Dis. 2020.

  4. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

  5. USP-NF Monograph: Berberine Hydrochloride. (Accessed July 2025).

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