Premium Berberine Hydrochloride Manufacturer
As a leading manufacturer of natural plant extracts, Chengdu Chenlv Herb Co., Ltd. provides premium bulk Berberine HCl 98% directly from our state-of-the-art facility. Our Berberine Hydrochloride is isolated and purified from sustainably sourced botanical raw materials, including Phellodendron amurense and Berberis aristata, using advanced green extraction methodologies.
Designed for global pharmaceutical, nutraceutical, and dietary supplement formulations, our active pharmaceutical ingredient (API) meets and exceeds rigorous compendial requirements. Every batch undergoes comprehensive testing to verify identity, purity, and potency, guaranteeing that you receive consistent quality for your commercial scale production.
Compendial Reference
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USP Standard: Strict assay limits (98.0%–102.0% on dried basis) with tight chromatographic purity controls.
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EP Standard: Rigorous limits on related alkaloids (jatrorrhizine, palmatine) and ash content.
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CP Standard: Confirms identity via IR/UV spectrum analysis and guarantees low moisture absorption.
Uncompromising Quality Control Standards
Our dedication to safety and efficacy is backed by advanced analytical testing protocols. We implement rigorous checks at every phase of production, from raw material validation to final product dispatch.
Heavy Metals & Pesticides
We utilize ICP-MS (Inductively Coupled Plasma Mass Spectrometry) to detect trace elemental impurities. Our limits strictly comply with USP and EP guidelines: Lead (Pb) < 0.5 ppm, Arsenic (As) < 0.5 ppm, Cadmium (Cd) < 0.1 ppm, and Mercury (Hg) < 0.1 ppm. Additionally, screen assays cover over 400 pesticide residues to ensure zero agricultural contamination.
Solvent Residue Management
Our extraction processes utilize green solvents (purified water and food-grade ethanol). Residual solvents are analyzed via Headspace Gas Chromatography (HS-GC). Ethanol residues are kept well below 5,000 ppm, and toxic solvents like methanol, benzene, or chlorinated hydrocarbons are completely excluded, ensuring a clean, non-toxic ingredient profile.
Microbiological Sterility
Operating under GMP-compliant environments, we verify microbiological purity for every batch. Total Aerobic Microbial Count (TAMC) is maintained < 1,000 CFU/g, and Total Combined Yeasts and Molds Count (TYMC) is kept < 100 CFU/g. Pathogens including Escherichia coli, Salmonella, and Staphylococcus aureus are guaranteed absent.
Technical Specification Sheet (HPLC 98%)
Review the exact physical, chemical, and structural parameters of our Berberine Hydrochloride. Customize particle sizes and bulk densities are available to meet your specific encapsulation or tableting needs.
| Parameter / Test Item | Standard Specification Limit | Analytical Method / Equipment |
|---|---|---|
| Appearance | Yellow crystalline powder | Visual Inspection |
| Assay (Berberine HCl) | ≥ 98.0% (on dried basis) | HPLC (High-Performance Liquid Chromatography) |
| Particle Size (Mesh) | 100% through 80 mesh (customizable to 100 or 120 mesh) | Sieve Shaker Analysis |
| Bulk Density | 0.45 g/ml – 0.65 g/ml | Tap Density Tester |
| Solubility | Slightly soluble in cold water; freely soluble in hot water; sparingly soluble in ethanol | USP Solubility Protocol |
| Loss on Drying | ≤ 12.0% (typically 8.0% - 11.5%) | Moisture Analyzer (105°C, 5 hours) |
| Residue on Ignition | ≤ 0.1% | Muffle Furnace (600°C) |
| Related Substances (Jatrorrhizine, Palmatine) | Individual impurity ≤ 1.0%; Total impurities ≤ 2.0% | HPLC Gradient Method |
Technical FAQ: Stability, Bioavailability & Formulation
Get expert insights on how high-purity Berberine HCl behaves in different formulations, its chemical stability, and compounding strategies.
What is the thermal and pH stability profile of Berberine HCl 98%?
Berberine Hydrochloride exhibits excellent thermal stability in solid state, resisting degradation at temperatures up to 80°C, making it suitable for standard tablet pressing and wet granulation. In aqueous solutions, it is most stable within a pH range of 4.5 to 6.5. Exposure to strong alkaline environments can cause chemical structural changes and discoloration, so formulators should avoid high pH excipients.
How can formulators overcome the low bioavailability of Berberine?
To enhance intestinal absorption, developers often pair Berberine HCl with bio-enhancers or absorption promoters. Synergistic ingredients like Caprylic Acid (a medium-chain fatty acid), Piperine (black pepper extract), or P-glycoprotein (P-gp) inhibitors significantly increase systemic bioavailability. Liposomal delivery systems and self-emulsifying drug delivery systems (SEDDS) are also emerging as highly effective methods.
Which active ingredients pair best with Berberine in dietary supplements?
For metabolic health and blood sugar support formulations, Berberine HCl is frequently compounded with Chromium Picolinate, Alpha-Lipoic Acid (ALA), Cinnamon Bark Extract, and Gymnema Sylvestre. For cardiovascular health, pairing it with Red Yeast Rice (containing Monacolin K) or Coenzyme Q10 provides highly synergistic benefits.
What are the recommended storage conditions to prevent moisture absorption?
Berberine HCl is slightly hygroscopic. It should be stored in tightly sealed, double-layer food-grade polyethylene bags inside fiber drums. Keep the storage environment cool, dry, and dark (temperature < 25°C, relative humidity < 60%). Under these conditions, the product maintains a stable shelf life of 24 to 36 months.
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About Us
Chengdu Chenlv Herb Co., Ltd.
Chengdu ChenLv Herb Co.,Ltd. (referred to as "Chenlv Herb") was established in 2012 as a high-tech enterprise specializing in the R&D, production, and sales of botanical extracts and natural pharmaceutical ingredients. Committed to providing high-purity, highly active, and premium-quality natural raw materials, the company serves diverse industries, including pharmaceuticals, health supplements, food, and cosmetics.
Our advanced production lines operate under strict GMP guidelines, ensuring complete traceability and quality control from raw materials to final packaging. We focus on building long-term relationships with global B2B clients by offering reliable supply, custom specifications, and comprehensive technical support.
READ MORE ABOUT USOur Advantages
Choose Chenlv Herb for products that deliver beyond expectations. We combine technical innovation, quality assurance, and dedicated service.
Request a Free Sample & COA
Are you formulating a new dietary supplement or looking to switch to a more reliable, high-purity Berberine HCl supplier? We offer comprehensive documentation (COA, MSDS, Allergen Statement, GMO Statement) and free testing samples for qualified B2B buyers.
Our technical team is ready to support your formulation challenges. Fill out the request form, and our sales representatives will contact you within 12 hours with pricing, shipping options, and technical specifications.
Chengdu Chenlv Herb Co., Ltd.
Factory Address: Chengdu Botanical Extraction Zone, Sichuan, China
Email: info@chenluextracts.com | Tel: +86-28-XXXXXXXX
GMP Certified Manufacturing Plant