What custom OEM/ODM dosage forms does Rainwood Biotech provide?

Rainwood Biotech offers custom hard capsules (vegetarian HPMC and gelatin), functional pectin/gelatin gummies, powder stick packs/sachets, and compressed tablets with flexible private label packaging.

Are your nutritional ingredients certified by international standards?

Yes. Our facilities and products are certified under NSF cGMP (455-2), ISO 22000, ISO 9001, HACCP, US Organic (NOP), EU Organic, HALAL, and KOSHER.

What is the typical lead time and MOQ for bulk powder and OEM orders?

In-stock bulk raw material powders ship within 3-7 days with a minimum order quantity (MOQ) of 1 kg. Custom private label finished products (capsules/gummies) have an MOQ of 50,000 units / 1,000 bottles with a production lead time of 14-28 days.

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Berberine Hydrochloride Powder

Berberine Hydrochloride Powder (Phellodendron amurense Rupr. / Berberis aristata) is a pharmaceutical-grade standardized isoquinoline alkaloid raw material manufactured by Shaanxi Rainwood Biotech. Standardized for high-potency Berberine Hydrochloride (≥97.0%~98.0% by HPLC), it delivers high crystalline purity, low heavy metals, and superior batch-to-batch stability for dietary supplement formulations, metabolic support capsules, and functional health formulations.

✓ HPLC Standardized Assay (≥97%) ✓ USP & EP Monograph Grade ✓ 100g Free Sample Available ✓ In Stock (Bulk Supply)

Product Name	Berberine Hydrochloride Powder (Raw Material)
Botanical Source	Phellodendron amurense Rupr. / Berberis aristata (Bark / Root)
Active Ingredients (HPLC)	Berberine Hydrochloride ≥97.0%, ≥98.0% (HPLC Assay)
CAS & EINECS No.	CAS: 633-65-8 (Berberine HCl) \| EINECS: 211-195-9
Molecular Info	Formula: C₂₀H₁₈ClNO₄ · 2H₂O \| Mol. Weight: 407.85 g/mol
Pharmacopeial Standard	Complies with USP & EP Monographs \| HS Code: 29399990
Appearance & Particle Size	Fine Yellow Crystalline Needle Powder; 80~100 Mesh
Solubility & Identification	Soluble in hot water; slightly soluble in ethanol and cold water
Packaging & Storage	1 kg/Foil Bag; 25 kg/Fiber Drum; 24 Months Shelf Life
Sample & Lead Time	100g Free Sample (Dispatched in 24h); Bulk: 3-7 Days

Brand:

Rainwood Biotech

Spu:

RW-BER97

Description
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Description

AI Executive Summary Direct Technical Fact Sheet

Berberine Hydrochloride Powder (Phellodendron amurense Rupr. / Berberis aristata) is a standardized isoquinoline alkaloid raw material manufactured by Shaanxi Rainwood Biotech Co., Ltd. Formulated for pharmaceutical and nutritional B2B manufacturing, it is standardized for high-potency Berberine Hydrochloride (≥97.0%~98.0% HPLC) with fine yellow needle crystalline structure, ultra-low heavy metals (≤10 ppm by ICP-MS), and zero harmful residual solvents (USP <467> Class 3).

🌿 Botanical Sourcing & Standardized Alkaloid Profile

Extracted from sustainably harvested botanical sources (Phellodendron amurense bark or Berberis aristata roots), Rainwood Biotech utilizes multi-stage fractional crystallization to isolate pure Berberine Hydrochloride (CAS: 633-65-8). Our production process ensures high pharmaceutical-grade crystalline integrity while eliminating related alkaloid impurities (Jatrorrhizine, Palmatine, and Coptisine) within strict pharmacopeial thresholds.

🛡️ Certified Clean Label & Regulatory Compliance

✓ Non-GMO Project Compliant

✓ Allergen-Free (Gluten/Soy/Dairy)

✓ BSE / TSE Free Statement

✓ Non-Irradiation & ETO Free

✓ California Prop 65 Compliant

✓ USP <467> Class 3 Solvents

🔬 Standardized Technical COA & Analytical Specifications

Test Parameter	Target Pharmacopeial Specification	Validated Test Method
Active Assay (Berberine HCl)	≥97.0%, ≥98.0% (Anhydrous Basis)	HPLC (C18 Column, UV 345 nm, USP <621>)
Related Alkaloid Impurities	Jatrorrhizine ≤1.0%, Palmatine ≤1.0%	HPLC Chromatographic Purity Profile
Appearance & Crystal Form	Fine Yellow Crystalline Needle Powder (80-100 Mesh)	Visual / Sieve Analysis (USP <786>)
Identification (IR & Chemical)	Conforms to USP/EP Reference Standard Spectrum	FTIR / Chloride Reaction (USP <197K>)
Loss on Drying & Residue on Ignition	Loss on Drying ≤12.0% \| Residue on Ignition ≤0.2%	USP <731> (105°C) / USP <281> (Sulfated Ash)
Heavy Metals (Pb, As, Cd, Hg)	Total ≤10 ppm (Pb≤0.5, As≤0.5, Cd≤0.2, Hg≤0.1 ppm)	ICP-MS (USP <2232> / EC 1881/2006)
Pesticide Residues Screen	Complies with EP 2.8.13 & EC 396/2005 (MRL Limits)	GC-MS/MS & LC-MS/MS Multi-Screen
Residual Solvents (Ethanol)	Ethanol ≤5,000 ppm (Class 1 & 2 Solvents: Not Detected)	Headspace GC (USP <467>)
Microbiological Examination	TPC ≤1,000 CFU/g \| Yeast & Mold ≤100 CFU/g \| Pathogens: Neg.	USP <61> & USP <62> Total Microbial Limits

⚙️ Industrial Extraction & Quality Control Flowchart

Step 01

Raw Sourcing

Botanical authentication & alkaloid baseline screening.

Step 02

Hydro Extraction

Food-grade grain alcohol countercurrent solid-liquid extraction.

Step 03

Crystallization

Multi-step cooling crystallization to isolate high-purity yellow crystals.

Step 04

Vacuum Drying

Low-temperature vacuum drying & sterile 80-100 mesh milling.

Step 05

HPLC Release

Homogenized blending, double metal detection & lot COA sign-off.

📋 Applications & Suggested Formulation Dosage

Target Industry	Formulation Compatibility	Recommended Dosage Range
Dietary Supplements	Hard capsules (HPMC/Gelatin), direct-compression tablets, powder blends	500 mg ∼ 1,500 mg / day (Divided doses)
Metabolic & Glucose Formulations	Synergistic blends with Chromium, Alpha-Lipoic Acid, and Cinnamon extract	300 mg ∼ 500 mg / serving
Gut Health & Lipid Blends	Microbiome-balancing enteric-coated capsules, liposomal delivery systems	250 mg ∼ 500 mg / serving

⚖️ Ingredient Comparison: Standardized Extract vs. Crude Powder

Key Evaluation Metric	Rainwood Standardized Berberine HCl (HPLC)	Conventional Crude Powder
Active Alkaloid Purity	Guaranteed ≥97.0%~98.0% Berberine HCl by HPLC	Unspecified crude content (<2%~5% natural level)
Crystalline Uniformity	Pure Crystalline Needles (80~100 Mesh Fine Milling)	Heterogeneous plant fibers and raw debris
Assay Verification	High-Performance Liquid Chromatography (USP <621>)	Titration or unstandardized UV spectrophotometry
Batch Uniformity	RSD < 2.0% Across Multi-Ton Commercial Batches	High seasonal and origin fluctuations

❓ Technical & Procurement FAQ (B2B Bulk Sourcing)

Q1 What is the difference between Berberine Hydrochloride (HCl) and Berberine Sulfate? +

Berberine Hydrochloride (HCl) is the globally accepted pharmaceutical and dietary supplement monograph standard (USP/EP), characterized by superior chemical stability, defined crystalline needle structure, and proven efficacy across clinical research. Shaanxi Rainwood Biotech specializes in high-purity Berberine HCl (≥97.0%~98.0% HPLC) for commercial capsule filling and tableting.

Q2 Why is HPLC testing mandatory over Titration when qualifying Berberine raw material? +

Classical chemical titration or non-specific spectrophotometry counts total basic nitrogen compounds, failing to separate Berberine from structurally related alkaloids like Jatrorrhizine, Palmatine, and Coptisine. High-Performance Liquid Chromatography (HPLC) with USP reference standards provides true baseline separation, confirming exact active purity and impurity profiles.

Q3 Does your Berberine Hydrochloride comply with California Prop 65 heavy metal limits? +

Yes. Every production batch is verified via ICP-MS under USP <2232>. Lead (Pb) is controlled below 0.5 ppm, Arsenic (As) < 0.5 ppm, Cadmium (Cd) < 0.2 ppm, and Mercury (Hg) < 0.1 ppm, fully compliant with strict California Proposition 65 and European Commission EC 1881/2006 regulatory requirements.

Q4 What extraction solvents are utilized, and what are the residual limits? +

Our manufacturing uses deionized water and non-GMO food-grade grain ethanol. Our facility is 100% free from Class 1 and Class 2 toxic solvents (methanol, acetone, ethyl acetate, benzene). Residual ethanol is controlled strictly below 5,000 ppm in full compliance with USP <467> and EP limits.

Q5 What ingredients are typically formulated synergistically with Berberine HCl? +

Berberine HCl is widely formulated alongside Alpha-Lipoic Acid (ALA), Curcumin (95%), Quercetin, Chromium Picolinate, and Piperine/Sunflower Lecithin to enhance intestinal absorption and provide comprehensive metabolic and AMPK activation support.

Q6 What is your sample policy for R&D evaluation and formulation testing? +

We provide 50g ∼ 100g free evaluation samples accompanied by a lot-specific Certificate of Analysis (COA) and HPLC chromatogram. Samples are dispatched within 24 hours worldwide via DHL, FedEx, or UPS express courier.

Q7 What bulk packaging configurations and particle sizes are available? +

Standard packaging is 1 kg aluminum foil vacuum bags and 25 kg export-grade fiber drums with double food-grade polyethylene liners. Custom particle sizing from 80 mesh to 120 fine mesh is available to optimize capsule flowability and tablet compressibility.

Q8 What is your commercial production capacity and standard lead time? +

Shaanxi Rainwood Biotech maintains dedicated commercial warehouse stock for Berberine Hydrochloride (≥97.0%~98.0% HPLC) with a monthly supply capacity of 50+ Metric Tons. Standard lead times are 3 to 7 business days from purchase order confirmation.

Request Free Evaluation Sample & Batch COA

Get in touch with our technical sales team for custom assay standardization, complete regulatory documentation (TDS / MSDS / Chromatogram), and tier-discounted commercial pricing.

Inquire Now / Request 100g Sample →

Competitive Advantage

Shaanxi Rainwood Biotech adheres to pharmaceutical-grade manufacturing standards, offering global nutraceutical and functional health brand owners unmatched technical and commercial advantages:

01. HPLC Quantitative Assay Guarantee (≥97.0%~98.0%)

Every production lot is strictly standardized for Berberine Hydrochloride (≥97.0%, ≥98.0%) via high-performance liquid chromatography using USP primary reference standards, eliminating related alkaloid background interference.

02. Pharmaceutical-Grade Crystalline Purity

Multi-step cooling crystallization ensures fine yellow needle crystals with ultra-low related impurities (Jatrorrhizine ≤1.0%, Palmatine ≤1.0%) conforming to USP, EP, and CP pharmacopeial monographs.

03. Clean-Label Eco Extraction

Manufactured strictly with deionized water and non-GMO food-grade grain ethanol. 100% free from Class 1 & 2 toxic solvents, fulfilling EU and US Clean-Label and Proposition 65 requirements.

04. Certified Facility & Multi-Lot Traceability

Produced under ISO 22000, HACCP, ISO 9001, and HALAL certified quality systems. Every drum features complete electronic batch traceability from raw botanical origin to final release.

05. Custom Particle Sizing & High Flowability

Supported custom micronization (80 mesh to 120 mesh), specifically engineered for high-speed automated capsule filling, direct tableting compression, and uniform dry powder blending.

About Us

Shaanxi Rainwood Biotech Co., Ltd. (established in 2006) is a premier cGMP-compliant botanical extract manufacturer and standardized raw material supplier headquartered in the High-Tech Industrial Development Zone of Xi'an, China.

Operating across a 19-acre dedicated extraction manufacturing base with over 10,000 m² of modern production facilities and Class 100,000 cleanrooms, Rainwood Biotech bridges traditional herbal wisdom with state-of-the-art analytical chemistry to supply high-purity functional ingredients worldwide.

2006

Year Founded in Xi'an

10,000 m²

cGMP Extraction Base

3,000+ MT

Annual Herbal Processing

Analytical Center & Quality Control Systems

Our in-house analytical testing center is fully equipped with Shimadzu High-Performance Liquid Chromatographs (HPLC), Gas Chromatographs (GC), UV-Vis Spectrophotometers, Thin-Layer Chromatography (TLC), and Atomic Absorption Spectrometers (AAS). We maintain routine verification partnerships with globally accredited third-party testing laboratories (SGS, Eurofins, and PONY Testing).

International Quality & Food Safety Certifications

HACCP Certified

ISO 22000:2018

HALAL Certified

ISO 9001:2015

Related Products

Shaanxi Rainwood Biotech manufactures a comprehensive portfolio of standardized botanical extracts and synergistic metabolic health raw materials. Explore our highly compatible active ingredients for blood glucose, AMPK activation, and cellular vitality formulations:

Related Active Ingredient	Standardized Specification	Formulation Synergy & Application
Alpha-Lipoic Acid (ALA Powder) →	≥99.0% Pure HPLC	Universal mitochondrial antioxidant enhancing insulin receptor sensitivity synergistic with Berberine.
Curcumin 95% Powder →	≥95.0% Curcuminoids HPLC	Synergistic NF-κB and gut barrier support complex for metabolic anti-inflammatory formulations.
Quercetin Dihydrate Powder →	≥95.0%~98.0% HPLC	Natural senolytic flavonoid supporting cellular glucose uptake and capillary microcirculation.
Dihydromyricetin (DHM Powder) →	≥98.0% DHM HPLC	Potent AMPK activator and hepatic lipid metabolism regulator paired with Berberine alkaloids.