Berberine Hydrochloride

Berberine Hydrochloride is a high-purity, naturally derived quaternary ammonium alkaloid manufactured for commercial dietary supplement and pharmaceutical intermediate applications, delivering consistent assay values, low residual solvent profiles, and optimal powder morphology for efficient solid oral dosage manufacturing.

Molecular Data: C20H18ClNO4 formula weight 371.82 g/mol.

Solubility Properties: Sparingly soluble in water (approx 1 g/L at 20 deg C); soluble in boiling water and methanol.

Thermal Behavior: Softens and decomposes near 200 deg C to 205 deg C under standard atmospheric conditions.

Structural Stability: Maintains chemical integrity during standard dry powder processing and granulation.

Controlled Impurity Profile: Advanced crystallization restricts related substances and synthetic intermediates below strict regulatory thresholds.

Optimized Particle Size: Pulverized and sieved to d90 under 180 micrometers (90 percent passing 80-mesh), ensuring content uniformity in low-dose blends.

Green Solvent Control: Purified exclusively using class 3 solvents, maintaining residual levels well below ICH Q3C limits.

Excipient Compatibility: Stable interaction profiles with standard tableting binders including microcrystalline cellulose and magnesium stearate.

Moisture Sensitivity: Exhibits hygroscopic tendencies; requires climate-controlled granulation areas with relative humidity below 45 percent.

Flowability Optimization: Blending with colloidal silicon dioxide (0.5 percent to 1.0 percent) resolves hopper bridging during high-speed encapsulation.

Metabolic Health Formulations: Active ingredient for dietary supplement capsules targeting glucose pathways and lipid profiles.

Weight Management Products: Synergistic botanical additive formulated to support body composition management.

Chemical Synthesis: Utilized as an active biochemical intermediate in synthetic pathways requiring purified isoquinoline cores.

Heavy Metals Control: ICP-MS verification confirming Lead max 0.5 ppm, Arsenic max 0.5 ppm, Cadmium max 0.1 ppm, and Mercury max 0.1 ppm.

Microbial Limits: Total aerobic count max 1000 CFU/g; yeast and mold max 100 CFU/g; absence of pathogens.

Lot Traceability: Full backward and forward tracking connecting raw botanical source records directly to final container COA issuance.

Temperature Range: Store in a cool, dry environment maintained between 15 deg C and 25 deg C.

Light Protection: Keep containers tightly sealed and shielded from direct sunlight and ultraviolet exposure.

Moisture Barriers: Store on elevated pallets; ensure inner polyethylene liners are heat-sealed immediately after sampling.

Core Dossiers: Comprehensive documentation package including Certificate of Analysis (COA) and Safety Data Sheet (SDS).

TSE/BSE Compliance: Guaranteed free from animal-derived components and transmissible spongiform encephalopathy risks.

Residual Declarations: Official statements confirming full adherence to ICH Q3C solvent guidelines.

Primary Containment: Food-grade dual polyethylene bags hermetically heat-sealed against moisture ingress.

Secondary Containment: Rigid fiber drums reinforced with exterior sealing rings; net weight 25 kg per unit.

Freight Classification: Non-hazardous cargo approved for standard air, ocean, and land transport.

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