01. Berberine HCl Bulk Supplier — Procurement Summary
02. Manufacturer & Quality Assurance Platform
Audit-Ready Quality Assurance
AIHerba® moves beyond commodity-grade ingredients to pharmaceutical excellence. Our facility integrates Batch Traceability and Analytical Release protocols. Every lot is verified for the most demanding global markets, including USA and EU Clean Label standards.
03. Berberine HCl Identity Profile
| Chemical Name | Berberine Hydrochloride |
| CAS Number | 5956-60-5 / 633-65-8 (Anhydrous) |
| Molecular Weight | 371.81 g/mol |
| Source | Natural Bio-synthesis / Phellodendron bark isolate |
| Standard Grade | Japanese Pharmacopoeia (JP 18) / USP / CP 2020 |
04. Technical Specification & Release Standard
PURITY (HPLC)
LOSS ON DRYING
TOTAL ASH
TAPPED DENSITY
05. Analytical Verification & Scientific Fingerprint
Every batch of AIHerba® Berberine HCl undergoes multi-instrumental validation to ensure absolute molecular identity and safety.
06. Batch Release & Quality Control System
07. Manufacturing Process & Engineering Control
AIHerba’s manufacturing utilizes a Closed-Loop Ethanol Extraction and precision crystallization protocol. Our engineering team controls the cooling kinetics during the re-crystallization phase to ensure a narrow particle size distribution, yielding a free-flowing Granular habit that eliminates the common industrial challenge of powder clumping on high-speed lines.
08. Molecular Structure & Functional Characteristics
- Enhanced Solubility: Optimized for acidic media, ensuring superior stability in gastric environments.
- Bioavailability Mastery: Our JP 18 isolate is engineered for maximum mucosal uptake, allowing for lower dosage requirements.
- Thermal Stability: High resistance to humidity and oxidation, providing an extended shelf-life for complex formulations.
09. Engineering Module: Solving Flowability & Safety
Solution: Validated Steam-Sterilization only. 100% EtO Negative Guarantee via GC-MS/MS verification.
Impact: Dust-free 80-100 mesh granular form is perfect for Direct Compression (DC), improving production efficiency by 25%.
10. Formulation Development Guide
Solubility Matrix
Slightly soluble in water and ethanol. Stability is maximal in nitrogen-sealed environments. Recommended pH target: 4.5 – 6.5 for liquid intermediates.
Mixing Guidance
Our granular form requires low-shear mixing to maintain particle integrity before tableting. Compatible with MCC, Magnesium Stearate, and specialized lipids.
11. Stability & Transport Engineering
12. Regulatory & Compliance Documentation
13. Packaging Storage & Global Shipping
Standard Packaging: 25kg fiber drum. Export Support: DDP (Delivered Duty Paid) shipping to USA/EU/UK. AIHerba takes 100% responsibility for the ‘Red Zones’ of international trade, allowing your team to focus on growth instead of logistics friction.
14. Custom Specification & OEM Support
AIHerba offers specialized Granulation and Particle Engineering. We can provide customized mesh sizes (40-200 mesh) to match specific high-speed automated line requirements.
15. Berberine Market & Industry Insights
The global Berberine market is expanding at a 7.5% CAGR, driven by “Clean Label” demand. Sourcing managers are increasingly shifting from 95% generic grades to JP 18 Standard 97%+ to satisfy more stringent heavy metal audits in North America and the EU.
16. Market Benchmark: JP 18 vs. Standard Extract
| Feature | Standard Extract | AIHerba® JP 18 Grade | Procurement Advantage |
|---|---|---|---|
| Physical Form | Fine Powder (Dusty) | DC Granular | Zero Clumping; High-speed friendly. |
| Bioavailability | Variable (40-60%) | Optimized High-Uptake | Higher potency with lower dosage. |
| Safety Status | Risk of EtO residues | 100% EtO Negative | Satisfies strictest EU/US retailers. |
17. Technical Procurement FAQ
People Also Ask: Technical & Sourcing
What is the main advantage of JP 18 standard for Berberine HCl?
The JP 18 (Japanese Pharmacopoeia) is one of the world’s strictest standards. It requires a specific assay range (97.0% – 102.0%) and limits total impurities to ≤1.0%, which is superior to generic 95% extracts used in low-cost supplements.
How do you prevent Ethylene Oxide (EtO) contamination in Berberine?
AIHerba® utilizes pure ethanol crystallization and validated steam sterilization instead of chemical gases. Every batch is GC-MS tested to guarantee it is 100% EtO Negative (<0.01 mg/kg), meeting EU and US safety mandates.
Is your Berberine powder suitable for direct compression (DC)?
Yes. We provide an optimized granular form (80-100 mesh) specifically engineered for high-speed tableting. This reduces static charge, prevents clumping, and ensures weight consistency in finished dosage forms.
18. AIHerba Industrial Quality Commitment
✔ Batch Traceability
✔ Analytical Release
✔ Technical Dossier
✔ OEM Support
✔ Global Export
Contact our engineering department for samples or custom specifications.
1. Japanese Pharmacopoeia 18th Edition (JP 18) Monograph.
2. USP-NF Standards for Berberine Hydrochloride.
3. ICH Q3C Guidelines for Residual Solvents.
4. California Proposition 65 Compliance for Heavy Metals.
Disclaimer: This information is for B2B industrial procurement and R&D purposes only. Not intended for direct consumer diagnosis.





