Multi-Grade Applications · Epigoitrin HPLC-Verified · Pharma & Nutraceutical

Isatis Root Extract

Isatis indigotica Fort. · Brassicaceae · Chinese Pharmacopoeia 2020

Recognized globally as a premier broad-spectrum antiviral and immune-modulating botanical. Sourced from geo-authentic (Dao-Di) origins, we deliver fully traceable extracts across multiple specification grades—from sterile pharmaceutical formulations to highly soluble dietary supplement blends. Every batch is strictly standardized to Epigoitrin via HPLC, guaranteeing exact concentration ratios and uncompromised bioactivity from one transparent production chain.

100% Pure Extracts: Not Spray Dried onto a Maltodextrin Carrier Powder

Solvent-Free

100% extraction process

24

Months Retained batch samples · Stability data

4

Market sectors served

GMP

Certified 

Isatis Root Extract

Isatis indigotica Fort. · Radix Isatidis

Raw Isatis Root Powder

Isatis Root 10:1, 20:1, or custom

10:1 Epigoitrin ≧ 0.1% (HPLC)

15:1 Epigoitrin ≧ 0.2% (HPLC)

20:1 Epigoitrin ≧ 0.2% (HPLC)

Custom

GMP

Certified facility · Lushi

CoA

Issued for every batch

In-House Lab

Independent testing for every batch

CP 2020

Chinese Pharmacopoeia

R&D Team

PhD-led formulation support

Common Market Problems

What Isatis Extract buyers typically encounter

Early batches pass incoming QC. Later batches drift. The spec sheet promises a standard “10:1 extract” but deliberately omits the HPLC-verified Epigoitrin content. When field performance drops, you’re stuck talking to a broker who wasn’t in the lab and can’t pull a single production record.

We’ve mapped the most common failure points in Isatis root procurement — and the specific, factory-direct process decisions we’ve made to engineer each one out.

1. Vague "ratios" with zero active marker validation

"10:1 extract" merely describes a manufacturing process, not potency. Without HPLC-verified Epigoitrin levels, the true antiviral strength is unknown and impossible to validate across different batches.

2. Spring-harvested root disguised as premium material

Epigoitrin content in spring-harvested Isatis root can be 30–50% lower than autumn-harvested material. Unverified brokers mix harvest seasons, leading to weak, inconsistent field performance.

3. Hidden solvent residues and chemical processing

To cut corners, some mass-market producers use harsh chemical solvents (like methanol or acetone) during extraction, leaving toxic residues that fail clean-label nutraceutical standards.

4. Hidden dry-blending & poor encapsulation flow

Broker suppliers frequently dry-blend cheap maltodextrin into finished extract powders to artificially bulk up weight. This hidden dilution destroys potency consistency and causes severe clumping during capsule and tablet manufacturing.

5. Blind supply chains & zero post-delivery support

When a batch fails incoming QC weeks later, trading companies have no retained samples or production logs. Resolution becomes an endless commercial argument rather than a scientific determination.

1. Comprehensive In-House Analytics & Transparent CoAs

Every CoA clearly states the exact concentration ratio alongside the HPLC-quantified Epigoitrin content. Tested directly in our on-site QC lab equipped with high-precision HPLC, UV, and Atomic Absorption Spectrometry (AAS), we guarantee absolute potency and heavy-metal safety before any batch leaves our facility.

2. Strict Autumn Harvest & Dao-Di Ecological Sourcing

We exclusively source geo-authentic (Dao-Di) Isatis root harvested during the peak autumn window. Combined with strict ecological field management, we guarantee maximum natural active accumulation.

3. Pharma-Grade Extraction & Validated Recovery

We employ tightly controlled extraction matrices using only purified water or food-grade ethanol. Our advanced vacuum condensation systems ensure meticulous solvent recovery, guaranteeing every dispatched batch strictly passes USP/EP pharmacopoeia limits for residual solvents.

4. Transparent Formulation & Ideal Flowability

Zero post-production dry-blending. Carriers are used transparently during spray drying strictly for stability. Our Isatis extract delivers uniform particle sizing and excellent flowability/bulk density, and we also offer 100% carrier-free options tailored precisely for your manufacturing needs.

5. 24-Month Retained Library & Direct QA Access

We retain physical samples of every dispatched lot for 24 months. You communicate directly with our QA manager, complete with a formal root-cause analysis issued within 5 business days for absolute peace of mind.

Four Market Sectors

Isatis Extract — from pharmaceutical formulations to advanced immune support

Four standardized concentration grades cover every downstream application. Each grade is purpose-built for its sector, featuring dedicated production specifications, strict Epigoitrin standardization, and a tailored CoA template.

01

Drug Manufacturing

Isatis root is a cornerstone botanical in antiviral and immune-modulating medicines, globally recognized for its powerful efficacy against respiratory infections and seasonal viral outbreaks.

02

Nutraceuticals & Functional Foods

As global demand for natural immune defense surges, our Isatis root extract provides scientifically backed antiviral properties ideal for premium dietary supplements and functional clean-label formats.

03

Skincare & Personal Care

Rich in specific alkaloids and amino acids, Isatis extract offers potent anti-inflammatory and soothing benefits, making it an innovative botanical active for targeted dermatological and sensitive skin applications.

04

Animal Health & Feed Additives

A highly effective, natural alternative to antibiotics. Isatis root extract provides robust immune modulation and broad-spectrum antiviral defense for livestock and companion animals without residue concerns.

Five Product Forms

Isatis Root in the format your process actually needs

Each form is designed around a specific manufacturing workflow. Choose by your administration route, mixing equipment, and regulatory market.

01

Dry Powder Extract

Most concentrated form

Highly concentrated, spray-dried powder derived via water or ethanol extraction, with strictly standardized active markers. Offers excellent flowability and stability. Ideal for human dietary supplements (capsules/tablets) and serves as a premium feed additive base for livestock and aquaculture.

02

Fluid & Soft Extracts

Liquid concentrate

Premium liquid extracts optimized for rapid absorption and seamless formulation. Perfectly suited for cosmetic serums, personal care formulations, and high-purity oral liquid medications for both human and veterinary applications.

03

Soluble Granule

Instant dispersal

Engineered for complete and rapid water solubility without sedimentation. Perfect for human functional beverages and large-scale animal drinking water systems, ensuring zero clogging in automated farm dosing lines.

04

Custom Formulation

Targeted multi-industry solutions

Pre-blended synergistic formulas tailored to specific industry requirements. Whether formulating a complex nutraceutical or a specialized veterinary treatment, we customize active ratios to meet strict regional compliance and functional goals.

05

Raw Botanical Powder

Custom 60–500 mesh sizing

Premium botanical materials directly milled to precise particle sizes (60–500 mesh). This mechanical process retains the plant’s natural fiber and full-spectrum profile without extraction. A highly cost-effective solution ideal for human dietary capsules, herbal tea blends, and bulk animal feed premixes.

Grade Specifications

Chinese Pharmacopoeia compliance by application

Tailored extraction parameters and quality controls to meet the exact regulatory and formulation requirements of your sector.

Why strict Pharmacopoeia (CP) testing matters: Simple tests can be easily fooled by market adulteration. We protect your brand by strictly testing every batch against the rigorous analytical standards of the Chinese Pharmacopoeia (CP). This pharma-level methodology ensures authentic botanical identity, consistent potency, and zero compromise on quality.

Grade TARGET APPLICATION RATIO & EPIGOITRIN (HPLC) KEY SPECIFICATIONS IDEAL FORMAT
Pharmaceutical Grade
OTC cold formulas, Oral liquids, Compound granules
15:1 Extract (≥ 0.2% Epigoitrin)
Strict Pharmacopoeia compliance; In-house HPLC verified; Comprehensive heavy metal screening
Dry Powder / Granule
Nutraceutical & F&B Grade
Immune support capsules, Dietary supplements, Tablets
10:1 Extract (≥ 0.1% Epigoitrin)
100% aqueous extraction (Solvent-Free); Excellent flowability for encapsulation; Clean label compliant
Fine Powder
Cosmetic & Personal Care Grade
Anti-acne serums, Soothing lotions, Herbal facial masks
10:1 Extract (≥ 0.1% Epigoitrin)
Potent anti-inflammatory properties; Unadulterated natural botanical profile; INCI compliant
Dry Powder / Fluid Extract
Veterinary & Animal Nutrition Grade
Feed premix, Drinking water programs, ingection Grade
10:1 Extract (≥ 0.1% Epigoitrin)
Cost-effective botanical antiviral; High heat stability for pelleting; Strict ecological sourcing
Soluble Granule / Powder
Advanced Extraction Technology

Water or alcohol extraction— customized to your specifications. Centrifugal spray drying

Why the extraction method directly determines product quality: Water extraction preserves hydrophilic active ingredients, making it suitable for end products requiring a clean label. Ethanol extraction offers stronger selectivity for lipophilic (fat-soluble) active substances, which can significantly increase the extraction rate of target active ingredients and reduce the co-extraction of inactive impurities. We flexibly select the optimal extraction solution for you based on your application scenarios and target markets.

Both extraction routes connect to the same centrifugal spray drying system, protecting active ingredients with low temperatures throughout the entire process. From raw botanical materials to finished powders, the loss of active ingredients is < 3%.

or

Selected to your application

Pure Water Extraction

Using purified water as the solvent, multiple cycle extractions are performed on the botanical raw materials under controlled temperature and time conditions. The water extraction method can fully dissolve hydrophilic active ingredients, such as water-soluble flavonoids and polysaccharides. The resulting product features excellent water solubility and is ideal for health supplements, cosmetics, and veterinary applications that require “no organic solvent residues,” perfectly aligning with “clean label” standards in the EU and US.

Extraction Solvent

Purified Water

Extraction Temperature

80–95°C

Extraction Time

1.5– 2 hrs × 2-3 times

Solid-Liquid Ratio

1:10–15 (w/v)

Solvent Residue

Not Applicable

Applicable Certification

EU / US Clean Label

Ethanol Extraction

Using ethanol (typically 60–75% concentration) as the solvent, lipophilic (fat-soluble) active ingredients and specific aglycones are selectively enriched by adjusting the solvent polarity. Compared to water extraction, ethanol extraction can increase the yield of target active ingredients by 30–40%, while significantly reducing the co-extraction of hydrophilic inactive impurities (such as polysaccharides and mucilage), thereby streamlining subsequent purification steps. It is highly suitable for producing high-concentration botanical extracts and pharmaceutical-grade export products.

Extraction Solvent

60–75% Ethanol

Extraction Temperature

50–65°C

Extraction Time

1.5–2 hrs × 2-3 times

Solid-Liquid Ratio

1:10–12 (w/v)

Solvent Recovery

Closed reflux ≥ 90%

Residue Standard

ICH Q3C Class 3

Centrifugal Spray Drying

The concentrated water or ethanol extract enters the centrifugal spray drying tower, where a high-speed rotating atomizer disc disperses the liquid into uniform, fine droplets. This significantly increases the gas-liquid contact area, completing moisture evaporation in an extremely short residence time. The powder is dried and shaped before reaching the tower wall. The inlet air temperature is precisely controlled throughout the process, and the actual temperature of the material during drying does not exceed 55°C — ensuring that heat-sensitive active ingredients are completely preserved during the powdering process.

Atomization Method

Rotary atomization

Inlet air temperature

160–180°C

Actual material temperature

≤ 55°C

Powder moisture content

≤ 5%

Particle size range

20–80 μm

Activity retention rate

≥ 97%

Key Process Parameters

Actual Material Temperature

≤ 55 °C · Fully Monitored

Active Retention Rate

≥ 97 % · HPLC Verified

Finished Product Moisture Content

≤ 5 % · Drying Method

Particle Size Range

20–80 μm · Laser Particle Size

Compared to traditional spray drying: Traditional spray drying involves an inlet temperature exceeding 160°C, meaning materials are exposed to high temperatures for extended periods. The thermal degradation rate of heat-sensitive active components can reach 5–15%. Centrifugal spray drying drastically shortens droplet residence time via high-speed atomization. The actual temperature of the material never exceeds 55°C, keeping active loss < 3%. Liquids from both extraction routes can be fed directly into this system without needing equipment reconfiguration.

Compatible with Both Extraction Routes

Advanced Extraction Technology

The condenser valve stays open — for every hour, every batch.

Why this matters: During hot extraction, volatile oils — the terpene- and phenylpropanoid-based compounds responsible for much of a herb’s biological activity — vaporize with the solvent steam. In an open system with no condenser running, that steam vents to atmosphere, carrying the volatile fraction with it. The extract you end up with may pass an HPLC marker spec and still be missing 40–70% of its original volatile oil content. Running the reflux condenser throughout captures that steam, condenses it back to liquid, and returns it to the extraction vessel. Nothing leaves.

We operate our reflux condenser — with cooling water flowing and the condenser valve fully open — for the entire duration of every extraction run. Minimum run time is four hours. It costs more in electricity. We consider it non-negotiable.

Extraction without active reflux

Cooling water bypassed or switched off · Open-vent system

When the condenser valve is closed or the cooling water is off, the condenser becomes non-functional. Steam rising from the boiling extraction passes straight through and vents via the exhaust port. Monoterpenes, sesquiterpenes, and volatile phenylpropanoids — which are carried efficiently by steam even at temperatures well below their individual boiling points — are lost to the atmosphere continuously throughout the run.

Solvent heats; volatile oils vaporize and rise with steam toward condenser

Condenser inactive — no cooling; steam passes straight through without condensing

Steam vents through exhaust port; volatile oils exit with it — gone for good

This repeats every minute of the extraction run — losses accumulate over the full 4+ hours

40–70%

Typical volatile oil loss in an open-vent system

Varies by herb species, boiling point of target compounds, and run duration. Higher for monoterpene-rich herbs (mint, perilla, cyperus); somewhat lower for sesquiterpene-dominant herbs due to higher molecular weight.

Full reflux throughout the run

Cooling water flowing · Reflux condenser fully active · All 4+ hours

With the condenser valve open and cooling water circulating, the condenser maintains a temperature differential that causes rising steam to condense back to liquid on contact with the cooling surface. The condensate — solvent plus dissolved volatile oils — drips back into the extraction vessel. This cycle repeats continuously: vaporize, rise, condense, return. No volatile fraction escapes the system.

Solvent heats; volatile oils vaporize and rise with steam toward condenser

Condenser inactive — no cooling; steam passes straight Condenser active — cooling water flowing; steam contacts cold surface and condenses immediately without condensing

Condensate (solvent + volatile oils) drips back into extraction vessel — nothing lost

Cycle repeats continuously for the full run duration — volatile oil concentration in extract builds and holds
 

< 8%

Volatile oil loss with active reflux condenser

Residual losses attributable to minor condenser efficiency gaps and unavoidable head-space exchange during loading/unloading. The condenser itself retains >92% of the volatile fraction throughout the extraction cycle.

How the condenser is run

Parameters held for the full duration of every extraction batch

Condenser Valve

Fully open

Cooling Water

Continuous flow

Coolant Inlet Temp.

15–20°C

Condensation Zone

Shell-and-tube condenser

Condenser Active From

Pre-heat to drain

Volatile Oil Retention

≥ 92%

Exhaust Port

Closed during run

Run Duration (min.)

4 hrs (≥ 240 min)

Why pre-heat to drain? Volatile oil loss begins the moment the solvent starts warming — even before boiling. We open the condenser valve at the start of the pre-heat phase and keep it open through the full drain cycle. Any batch record showing condenser activation only after the target temperature is reached has already allowed early-phase losses.

What running it correctly costs

Per-batch energy consumption — extraction stage only

Electricity rate
100 kWh / hour

Extraction vessel + heating elements + cooling water pump

100 kWh / hour
Minimum run time
4+ hours / batch

Full reflux from pre-heat through drain — per batch

4+ hours / batch

For any herb where volatile compounds contribute meaningfully to the target bioactivity — or where the volatile fraction is part of the product’s organoleptic identity (flavour, aroma, or functional fragrance in cosmetic use) — open-vent extraction without active reflux produces a fundamentally different product. The marker compound on the CoA may look identical. The volatile oil profile will not.

FORMULATION INTEGRITY

Process aids for stability. Not cheap fillers for profit.

In botanical extraction, maltodextrin is often a necessary carrier during spray drying to prevent sticky resins from caking and to ensure powder flowability. We use it strictly as a functional manufacturing aid—never as a post-production filler. We guarantee 100% transparency on carrier ratios, and we never dry-blend maltodextrin into finished batches just to lower costs. Need a 100% pure extract? We also offer custom carrier-free processing tailored to your specific botanical requirements.

“There is a massive difference between using a 5% carrier during spray drying to ensure powder stability, and dry-blending 40% cheap carbohydrate into a finished drum to slash prices. One is formulation science; the other is specification inflation. We only practice the former.”

Dry-blending

The liquid botanical extract is blended with a high proportion of maltodextrin (a cheap, tasteless carbohydrate derived from starch) before spray drying. Maltodextrin acts as a “carrier” that improves flowability and reduces dust — but it permanently dilutes the active compound concentration in the final powder.

Transparent carriers & custom pure options

When we use maltodextrin, it is wet-blended before spray drying strictly to encapsulate botanical actives and improve flowability.

0%

Dry-Blended Fillers

No maltodextrin is ever mechanically mixed into finished powders to cheat on weight.

100%

Carrier Transparency

Exact excipient ratios are explicitly stated on your CoA for precise formulation dosing.

Custom

Carrier-Free Options

Depending on the species, 100% pure botanical extracts are available upon request.

Verified

Active Markers

Honest active compound reporting guarantees your final product’s therapeutic efficacy.

Raw Material Sourcing

We apply two binding criteria before a single kilogram enters our facility.

Most ingredient failures begin before extraction — not in the lab, but at the farm gate. Our procurement process enforces two independent standards that must be satisfied simultaneously. Neither alone is sufficient.

01

Geo-Authentic Origin And Qualified Supply Base

For botanical extracts, raw material quality is directly influenced by species identity, growing region, harvest season, climate, soil conditions, and post-harvest handling. We source raw materials from qualified producing regions and approved supply bases, with preference given to recognized geo-authentic origins where applicable.

Each incoming lot must be traceable to its declared botanical source, producing area, supplier, and harvest period. Mixed-origin, unclear-origin, or undocumented materials are not accepted for production, even when they appear to meet basic commercial specifications.

Verified Botanical Source

Each raw material must match the declared botanical species, plant part, and origin information. Supplier declarations are reviewed together with incoming inspection records to reduce the risk of substitution, adulteration, or mixed-origin material.

Documented Origin Per Incoming Lot

Every incoming lot is accompanied by supplier documentation, including origin information, harvest or collection records where applicable, and batch traceability documents. These records are archived and can be provided to customers upon request.

Harvest And Post-Harvest Control

Harvest season, plant maturity, drying method, storage condition, and transportation process are reviewed as part of incoming material evaluation. Materials showing signs of mildew, improper drying, abnormal odor, visible contamination, or poor storage are rejected.

Approved Supplier And Producing Area

We work with qualified suppliers and stable producing areas to reduce raw material variability. Supplier performance is evaluated continuously based on origin consistency, documentation reliability, incoming test results, and long-term batch stability.

02

Chinese Pharmacopoeia (CP 2020) — every parameter, every lot.

Origin alone is not sufficient. Each incoming raw material lot must pass identity, safety, and quality testing before it can be released for extraction or further processing. Our incoming inspection system is designed to confirm botanical authenticity, control contaminants, and maintain stable active-marker levels across production batches.

Testing requirements are established according to applicable pharmacopoeia standards, customer specifications, export market requirements, and internal quality limits. Any lot that fails an incoming inspection item is rejected or isolated for further investigation. There is no commercial override for out-of-specification raw materials.

TLC species authentication — every incoming lot

Thin-layer chromatography fingerprint comparison against CP 2020 reference standard. Confirms botanical identity and rules out adulteration with related Forsythia species or unrelated substitutes before acceptance.

Rigorous Macroscopic Sorting & Cleaning

Before processing, all raw herbs undergo comprehensive visual inspections. We strictly screen for and remove foreign matter, substandard pieces, and soil residues, ensuring only premium-grade materials enter our warehouse.

Active Marker Or Assay Testing

Key active markers or characteristic compounds are tested by HPLC, UV, TLC, or other validated methods depending on the botanical material and product specification. Internal acceptance limits are set to support stable extract potency and consistent finished-product performance.

Physical Condition & Milling Readiness

Before any material is cleared for custom milling, we evaluate its physical condition, drying state, and structural integrity. This ensures the raw herb is perfectly conditioned to achieve your exact mesh specifications and optimal flowability.

Pre-Purchase Active Compound Testing · Applied Before Any Lot is Accepted

We test target active compounds in the raw herb before procurement — not after.

The most common source of batch-to-batch inconsistency in botanical extracts is variability in raw material active compound density — which is invisible from the outside and undetectable by visual inspection alone. We address this at the point of origin: before any lot is commercially committed, a representative sample is submitted to our QC laboratory for quantitative analysis (e.g., HPLC/UV) of key active markers in the raw, unprocessed herb. Lots falling below our internal incoming material specification — set above the CP 2020 minimum — are rejected regardless of commercial pressure or supply availability. This pre-purchase testing step is what allows us to guarantee a finished extract specification rather than merely target it.

DIRECT MANUFACTURER • LUSHI FACILITY

Lushi — from raw herbs to export-grade extracts, all under one roof

Our facility is located adjacent to the primary botanical cultivation zones, with a fully integratedprocessing chain covering raw herb intake, primary processing, deep extraction, and finishedproduct QC release. Annual Chinese herbal processing capacity exceeds 10,000 MT. Serving all fourapplication grades, this makes us the largest and most vertically integrated botanical extractionoperation north of the Yangtze River.

23,000m²

GMP-certified production facility

9

Extraction Vessels

10,000+MT

Annual extract capacity

GMP

Certified facility
Third-party audits welcomed

Production Flow — From Fresh Fruit to Export-Grade Extract

01

Raw Material Intake & QC

Strict botanical verification

02

Water or Ethanol Extraction

Customized solvent route

03

Concentration

Low-temp evaporation

04

Spray Drying

Excellent flow & solubility

05

Comprehensive QC Testing

CoA issued

06

Packing & Dispatch

Global express

Certifications

Every document you need — prepared before you ask

Each certification was pursued because it solves a specific market access or buyer qualification requirement — not as a marketing exercise. We include scope, issuing body, validity period, and the market it is relevant to for every certificate.

Need originals for your supplier approval?

We dispatch full-resolution certificate scans, notarized copies, and issuing body contact details within 24 hours of request. No registration required.

iso

ISO 2200:2018

An internationally recognized standard for food safety management systems. This certification demonstrates our rigorous approach to identifying and controlling food safety hazards throughout the entire plant extraction process. It assures our global B2B clients in the feed additive and human health sectors that our materials meet the highest safety protocols from sourcing to final delivery.

haccp

HACCP

A globally recognized systematic and preventive approach to managing biological, chemical, and physical hazards in production. By strictly monitoring critical control points during botanical extraction, we eliminate contamination risks at the source. This rigorous risk management framework is essential for clients requiring absolute purity and uncompromised safety.

Food Production License

Food Production License

The mandatory official authorization issued by national market regulation authorities, legally permitting the production of food and dietary supplement ingredients. It signifies that our manufacturing facilities, sanitation protocols, and QC systems have passed stringent government inspections, ensuring our extracts are fully compliant for human health and high-end feed applications.

兽药GMP

GMP Certification

Pharmaceuticalgrade manufacturing standards applied to ourbotanical extraction operations. Significantly higher than standardfood-grade requirements -required by pharmaceutical clientsand veterinary drug manufacturers using our ingredients asstarting materials. Covers process validation,equipmentcalibration,environmental monitoring, and personnel training.

兽药生产许可证

Veterinary Drug Production License

Covers the entire process of veterinary drug production, testing, storage, and release. Strictly audited and issued by the national agricultural administration, proving full compliance with Veterinary GMP standards. This is the mandatory legal prerequisite for manufacturing and distributing veterinary pharmaceutical products, ensuring all batches are safe, effective, and quality-controlled.

兽药生产许可证

Business License

The fundamental legal document authorizing our corporate operations, issued by the State Administration for Market Regulation (SAMR). Verifies our registered capital, approved business scope, and legal representative. It serves as the legal foundation demonstrating full corporate legitimacy for all domestic and international commercial engagements.

ISO9001

ISO 9001 : 2015

Covers all production, testing, documentation, storage, and export processes. Audited annually by an accredited third-party certification body. Zero non-conformances in the last three consecutive audit cycles. The foundation standard required by most enterprise supplier qualification programs globally.

ISO14001

ISO 14001 : 2015

Internationally recognized standard for environmental management. Validates our commitment to minimizing our environmental footprint, reducing waste, and ensuring sustainable manufacturing practices. Covers wastewater treatment, emission controls, and resource efficiency. Essential for partnering with environmentally conscious global enterprises.

ISO45001

ISO 45001 : 2018

A comprehensive framework ensuring a safe and healthy workplace for all employees. Proactively prevents work-related injury and ill health through rigorous risk assessment and safety protocols. Covers hazard identification, emergency response mechanisms, and continuous safety training across all production facilities.

coa
R&D & TECHNICAL SUPPORT

The people behind the specification

We’re not a trading company. When you have a formulation question or a quality issue, you’re talking to the person who was in the lab. Every technical claim we make is backed by someone with direct production accountability.

A note on technical support: Our team handles formulation questions, dosage guidance, regulatory documentation, and compatibility questions as part of the standard buyer relationship — not as a paid consulting service. If you have a technical question before ordering, ask us.

Prof. Dr. Zhao Jinzhong

Chief Scientific Advisor

Over 20 years of expertise in medicinal chemistry and chemical biology. Lead researcher specializing in the discovery, extraction, and functional application of bioactive plant compounds. Has authored over 70 high-impact papers in leading international journals and holds multiple patents for natural product extraction technologies.

Prof. Dr. Zhang Yongpo

Senior R&D Scientist

Specializes in organic chemistry and the targeted extraction of natural active ingredients. Leads formulation methodology and coordination chemistry research to enhance the stability and bioavailability of botanical extracts. Published extensively in leading molecular structure and inorganic chemistry journals.

Dr. Yin Congcong

Lead Analytical Scientist

Senior experimentalist bridging raw material analysis with biochemical applications. Directs advanced laboratory testing protocols and biological activity evaluations to ensure absolute batch-to-batch consistency and active compound standardization.

Dr. Guo Dongdong

Extraction Process Engineer

Expert in green chemistry and advanced organic synthesis. Focuses on scaling up laboratory extraction parameters into highly efficient, sustainable industrial production lines, optimizing solvent routes and temperature controls to maximize active ingredient yields.

Quality System

Every batch tested. Every test published.

Our QC process reflects the dual-marker standard — both APS polysaccharides and Astragaloside IV on every production lot, not just on registration batches.

Incoming raw herb verification

Origin authentication, heavy metals (ICP-MS), pesticide residue (GC-MS/LC-MS), and TLC species confirmation before raw material enters production.

In-process and final product testing

Moisture, APS (UV), Astragaloside IV (HPLC), mesh size, microbiology. Final product CoA issued only after all parameters pass QA sign-off.

24-month retained sample program

Every production batch retained under controlled conditions for 24 months. Independent third-party retesting (SGS, Intertek, Bureau Veritas) accepted as binding on both sides.

QA-direct issue resolution

All quality claims handled by QA Manager — not routed through sales. Formal root-cause analysis within 5 business days. Resolution confirmed in writing before action taken.

GMP Certified

Veterinary extract facility

ISO 9001

Quality management system

Chinese Pharmacopoeia

CP 2020 full compliance

Export Certified

EU · US · SEA markets

"We publish the measured value, not just the minimum."

If APS tests at 73.4%, our CoA says 73.4% — not “≥70%”. That’s the difference between a document that proves quality and one that merely asserts it.

If APS tests at 73.4%, our CoA says 73.4% — not “≥70%”. That’s the difference between a document that proves quality and one that merely asserts it.

Packaging & Logistics

From our factory to your production line

Standard lead times, packaging options, and MOQ structure — so there are no surprises before your first order.

Sample Order

20-100g — Free Sample

Full CoA, spec sheet, and pricing indication included with every sample. Shipped globally within 48 hours of request.

  • Quantity 100g
  • Packaging Sealed foil pouch + desiccant
  • Shipping Express · SF/DHL / FedEx
  • Lead time 48 hours from request
  • Cost Free (all markets)

Trial Order

50 kg — formulation validation

Designed for formulation teams validating before committing to production volume. Available in all four application grades. Separate lot and dedicated CoA issued.

  • MOQ 50 kg per grade
  • Packaging 25kg drum (HDPE, UN-rated) or kraft bag
  • Shipping DAP / CIF · Buyer's preference
  • Lead time 7–10 business days
  • Documentation Full CoA + spec sheet

Production Order

1000 kg+ — standard commercial terms

Standard production orders available in 25 kg drums or 25 kg aluminum-lined kraft bags. Bulk pallet shipments on standard commercial trade terms.

  • MOQ 1000 kg per grade
  • Packaging 25kg drum (HDPE, UN-rated) or kraft bag
  • Shipping FOB Lanzhou / CIF destination
  • Lead time 15–20 business days (in-stock: 7 days)
  • Documentation Cool, dry · Below 25°C · Away from light

Shelf Life

24 months

Sealed, below 25°C, away from light and moisture

In-Stock Grades

All 4 grades

Drinking water · Feed mixing · Oral · Injection

Payment Terms

T/T 100%

Against B/L or CoA — negotiable for regular buyers

Private Label

Available

Custom packaging, label, spec format from 25 kg order

Technical FAQ

Questions buyers ask before placing a first order

Our technical team answers these most frequently. If yours isn’t here, ask us directly — technical consultation is a standard part of our buyer relationship, not a paid service.

What does the concentration ratio (20:1, 15:1, 10:1) actually mean? How is it verified?

The concentration ratio is a dry-weight measure: a 20:1 extract required 20 kg of dried Isatis root raw material to produce 1 kg of finished extract powder, after extraction, filtration, concentration, and drying. It reflects the overall botanical loading density of the finished product — not just the active compound percentage. We verify ratio by recording the dry weight of incoming raw material per batch and the finished extract yield, then calculating and documenting the actual ratio on the batch record and CoA. This makes the ratio independently auditable: if our incoming raw weight and finished product weight don’t produce the declared ratio within our validated tolerance, the batch is investigated before release.

Epigoitrin (R-goitrin, chemical name: (R)-5-vinyloxazolidine-2-thione) is a thiazolidine alkaloid derived from the glucosinolate sinigrin by enzymatic hydrolysis. It was selected as the CP 2020 legal marker for Radix Isatidis because it is structurally specific to the Brassicaceae family, traceable to Isatis indigotica rather than adulterant species, and quantifiable by HPLC-DAD with a well-validated method. Its antiviral mechanism is documented: epigoitrin inhibits influenza neuraminidase and has been shown to reduce viral replication in A and B influenza strains in vitro. However, it represents one part of the antiviral profile — indirubin, indigo, and nucleosides each contribute additional mechanisms. We report epigoitrin as the primary marker because it’s the CP 2020 requirement, but the full bioactivity of the extract reflects all constituent classes.

Injection grade (20:1) requires a full suite of parenteral-specific testing in addition to the standard QC panel. Sterility testing per CP 2020 (membrane filtration method for liquids, direct inoculation for solids). Endotoxin (bacterial endotoxin test, LAL method): ≤0.25 EU/mg. Subvisible particulates per CP 2020 injection preparation requirements. Pyrogen testing (rabbit pyrogen test or monocyte activation test depending on destination pharmacopoeia). All injection-grade production is carried out in our ISO 8 classified cleanroom with continuous environmental monitoring (viable and non-viable particulate counts). The cleanroom is physically separated from oral and feed production areas with separate HVAC, gowning, and personnel flow. Cleaning validation documentation is available for qualified pharmaceutical manufacturer audits.

Isatis root has a long history of use in Chinese veterinary medicine without documented toxicological concerns at recommended doses. The compound epigoitrin is a goitrogen at high doses (hence the name), but in vivo studies confirm that epigoitrin at typical inclusion rates in drinking-water programs does not produce measurable thyroid disruption in poultry or swine. For drinking-water dosing in poultry at typical 5–7 day program lengths, no withdrawal period concerns have been documented in published literature. However, regulatory status varies by market and species: in the EU, botanical feed materials under Reg. 767/2009 are not subject to withdrawal period requirements as long as no efficacy claims are made, but national competent authorities may interpret this differently. Our technical team can provide the relevant regulatory guidance notes and available safety data for your specific target species and market.

Our oral-grade extract (15:1) is used in cosmetic applications after standard formulation adaptation. Key parameters: the extract is water-soluble and compatible with aqueous and hydroalcoholic formulation bases. Stable pH range: 4.5–8.0 — compatible with most skincare formulations. The indirubin and indigo content produces a slight blue-grey tint at higher inclusion rates (above approximately 0.5% w/w); formulation teams typically work at 0.1–0.3% inclusion where the tint is minimal. Compatibility testing with common preservatives (phenoxyethanol, benzyl alcohol) and emulsifiers has been conducted — results available on request. Residual solvent levels comply with ICH Q3C class 3 limits. We can supply a cosmetic-specific technical dossier including INCI designation guidance, safety assessment data summary, and regulatory notes for EU Cosmetics Regulation (1223/2009) compliant formulations.

Standard documentation per batch: ① Certificate of Analysis (CoA) with actual measured values for epigoitrin (HPLC), concentration ratio verification, heavy metals (Pb, Cd, Hg, As), microbiology (total plate count, E. coli, mold, yeast), moisture, particle size, ash, and dissolution rate — all reported as actual results, not specification ranges; ② Certificate of Origin; ③ Phytosanitary Certificate; ④ Safety Data Sheet (SDS); ⑤ Health Certificate from the relevant provincial Department of Agriculture and Rural Affairs. For EU destinations: customs commodity code confirmation and REACH exemption statement. For injection grade: additional sterility, endotoxin, and particulate test certificates. All documents available for electronic pre-review before B/L issuance.

What is the regulatory status of Isatis root extract in the EU and US markets?

EU health supplement / botanical medicine: Isatis root is listed in the EFSA database of botanical substances with a history of use in traditional European herbal medicine. It can be registered under THMPD (2004/24/EC) as a traditional herbal medicinal product, or marketed as a food supplement provided no medicinal claims are made. The alkaloid content (indirubin) may require assessment depending on concentration and application. EU feed / veterinary: classified as a botanical feed material under Regulation (EC) 767/2009; no therapeutic claims permitted. The presence of glucosinolates requires documentation of anti-nutritional factor levels for certain species (particularly in feed applications at higher inclusion rates). US supplement (DSHEA): Isatis root is sold in the US supplement market without FDA pre-market approval; an NDI notification may be required for specific product forms. US veterinary / animal feed: generally positioned as a botanical feed ingredient. Our export technical manager can provide a market-specific regulatory advisory memo for your target use case at no charge before your first inquiry.

Glucosinolates are naturally present in Isatis root as precursors to the active compound epigoitrin, and this is well documented. At the inclusion rates typically used in drinking-water programs for poultry and swine (equivalent to 0.5–2 g/L of 10:1 extract), the glucosinolate contribution is substantially below the anti-nutritional thresholds documented for monogastric species. The concern is more relevant for ruminants at high continuous doses, which is not the typical usage pattern. Our drinking-water grade CoA includes total glucosinolate content as an informational parameter, and we provide species-specific inclusion rate guidance in our technical data sheet. For feed premix applications at higher inclusion rates — or for species where glucosinolate sensitivity is documented — we can recommend specific maximum inclusion rates and can assist in designing dosing programs that maintain therapeutic efficacy while staying below anti-nutritional thresholds.

Yes. We can produce concentration ratios above 20:1 on request — typically 25:1 or 30:1 for high-potency pharmaceutical applications. Higher ratios require a larger raw material input per unit of finished extract and extended production scheduling (4–6 weeks), with pricing scaled accordingly. For higher epigoitrin content above 0.2%, additional purification steps (column chromatography fractionation) are required; our validated process currently produces up to ≥0.5% epigoitrin with a 30:1 ratio for specialized pharmaceutical submissions. Please note: at very high concentration ratios, the extract becomes increasingly hygroscopic. We adjust packaging (nitrogen-flushed, double-sealed foil) and storage recommendations accordingly. If you have a specific target ratio and epigoitrin specification, provide your requirement and we’ll confirm feasibility and pricing within 48 hours.

Yes — and this is one of our most frequently requested compound formulations. The classical “Shuanghuanglian”  formula — combining honeysuckle (Lonicera japonica), forsythia (Forsythia suspensa), and Isatis root — has a well-documented antiviral synergy profile and is one of the most prescribed TCM antiviral formulations. We produce a standardized compound version of this combination in both oral and drinking-water grade: each component is independently standardized by HPLC before blending, the final compound is retested for all three primary markers (chlorogenic acid for honeysuckle, forsythin for forsythia, epigoitrin for Isatis), and a unified CoA is issued for the blend. Custom ratios of the three components are available. This is fully produced from ingredients manufactured in-house — no multi-supplier coordination required. Speak to our technical team about your target species, application, and market requirements.

Yes, from 25 kg per SKU. Private label services: custom product name and label; custom CoA format (issued under your company name or in dual-brand format); custom specification ranges within our manufacturing capability; packaging format selection (1 kg, 5 kg, 25 kg bags or drums). All OEM discussions are conducted under NDA. We do not require disclosure of your end customer, formulation details, or downstream pricing. ODM compound formula development: for clients developing a proprietary antiviral compound blend (e.g., Isatis + forsythia + honeysuckle at custom ratios), we handle the full formulation development, stability validation, and quality standard establishment. First private label batch: 4–6 weeks from specification agreement and NDA signature.

Contact our QA Manager directly by email or WhatsApp with the lot number, your specific test result and deviation, and the test method used. We acknowledge within 4 business hours. Our QA Manager has direct access to the retained batch sample (held for 24 months under ICH conditions), the full production batch record, and the original incoming material data. A formal root-cause analysis report is issued within 5 business days. If your test method and ours disagree, we first compare methodologies to rule out procedural differences — epigoitrin HPLC results can vary by up to 10–15% between different validated methods, and this is worth establishing before escalating. If a genuine quality discrepancy is confirmed, we accept third-party arbitration by SGS, Intertek, or Bureau Veritas as binding, with arbitration costs borne by the responsible party. Resolution options — replacement, credit note, or full refund — are confirmed in writing before action. We do not use delay as a dispute response strategy.

Commonly Paired With

Botanicals frequently combined with Isatis root in formulation

The following are most frequently requested alongside forsythia. All available in the same four product forms from the same facility — consistent quality, single-source supply chain.

Lonicera japonica 

Scutellaria baicalensis 

Forsythia suspensa 

Astragalus membranaceus

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