Berberine Hydrochloride for Nutraceutical and Dietary Supplement Formulations
Berberine Hydrochloride (Berberine HCl) is a standardized, high-purity active ingredient supplied in powder form for nutraceutical, dietary supplement, and functional nutrition formulations.
Key Product Specifications
|
Parameter |
Specification |
|
Product Name |
Berberine Hydrochloride |
|
Common Name |
Berberine HCl |
|
CAS Number |
633-65-8 |
|
Molecular Formula |
C20H18ClNO4 |
|
Molecular Weight |
371.81 g/mol |
|
Appearance |
Yellow to light yellow crystalline powder |
|
Assay (HPLC) |
>= 97.0% (or tailored to agreed customer standard) |
|
Identification |
Positive by HPLC / Infrared Spectroscopy (IR) |
|
Loss on Drying |
<= 12.0% |
|
Heavy Metals |
Lead <= 3.0 mg/kg, Arsenic <= 2.0 mg/kg, Cadmium <= 1.0 mg/kg, Mercury <= 0.1 mg/kg |
|
Microbiological Limits |
Total Plate Count <= 1,000 CFU/g, Yeast & Mold <= 100 CFU/g, E. coli (Negative), Salmonella (Negative) |
|
Residual Solvents |
Meets USP / EP requirements |
|
Standard Packaging |
25 kg/fiber drum with double food-grade PE inner bags |
|
Storage Conditions |
Sealed, cool, dry place, protected from direct heat and light |
Analytical Testing and Precision Dosage
HPLC Quantification: High-Performance Liquid Chromatography (HPLC) is used for active identification and quantitative purity testing.
Batch-Specific Potency: Formulators should use the actual assay percentage reported on the lot COA rather than nominal estimates when calculating input weight for finished formulations.
Botanical Source and Traceability
Berberine can be isolated from various plant species (such as Phellodendron amurense or Berberis aristata). Because plant origin influences the impurity profile and regulatory status, we provide full transparency for each production lot:
Exact botanical name and plant part used
Geographical origin of raw botanical material
Extraction and isolation route details
Full lot traceability from raw plant to finished powder
Manufacturing and Quality Control
Raw Material Inspection: Inbound raw botanicals are tested for identity, purity, and safety parameters prior to processing.
In-Process Controls: Critical extraction, crystallization, and drying parameters are closely monitored to preserve material consistency.
Finished Product Release: Every production lot is comprehensively tested for assay potency, heavy metals, pesticides, residual solvents, and microbiological safety before lot release.
Technical Considerations for Formulators
|
Formulation Factor |
Technical Challenge |
Recommended Solution |
|
Bitter Taste |
Naturally intense bitter flavor profile. |
Use solid oral dosage forms (capsules/tablets) or apply taste-masking, microencapsulation, or flavor systems for powders. |
|
Yellow Color |
Strong natural yellow hue may impact product optics. |
Evaluate aesthetic impact during prototype trials for white tablets, clear gummies, or light powder blends. |
|
Solubility |
Moderate aqueous solubility. |
Perform preliminary solubility trials in target liquid media; best suited for solid oral dosage forms. |
|
Active Calculation |
Assay variation between batches. |
Adjust raw material input based on actual HPLC assay percentage on the batch COA. |
Common Dosage Applications
Capsules: Ideal for direct powder filling into hard gelatin or vegetable capsules, avoiding taste challenges.
Tablets: Suitable for direct compression or wet granulation upon evaluation of flowability and binder compatibility.
Powder Blends: Easily incorporated into metabolic functional powder mixes with proper homogenization.
Multi-Ingredient Formulations: Compatible with synergistic botanicals, vitamins, and minerals (compatibility testing recommended).
FAQ
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