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Troxerutin Powder

1.Botanical Source: Sophora japonica L.
2.Specification: Troxerutin 95%
3.Appearance: Yellow Powder
4.CAS NO: 7085-55-4
5.Main Market: European, North America, Asia
6.Packing Specification: 25kg/drum, 27 drums/tray
7.Delivery: 3-7working days
8.Certification: FSSC,cGMP,KOSHER,HALAL,BRC,ORGANIC,ISO9001,ISO22000 etc.
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  • Product Description

High-Purity Troxerutin Powder API | FDA/EMA-Compliant

Are you looking for a reliable supplier of pharmaceutical-grade troxerutin powder that meets your high-quality standards? Shaanxi Hongda, as China's top nutritional supplement manufacturer, delivers troxerutin with a purity of at least 98%, meeting the regulatory standards of all global markets. Our high-quality troxerutin extract, produced in advanced cGMP facilities, is used as a raw material for treating hemorrhoids, venous insufficiency, and cardiovascular disease. Whether you're producing pills, capsules, or injectable solutions, our trusted supply chain ensures smooth production schedules while meeting the highest pharmaceutical industry standards.

Shaanxi Hongda's troxerutin extract is produced and supplied using a core directed catalytic ethylation process. We not only ensure a stable purity of over 99.0%, but also ensure extremely high solubility in water (1g soluble in 7ml of water) through molecular weight distribution control technology. Today, troxerutin, by promoting local blood circulation and combating oxidative stress, has become a core ingredient in high-end repair serums for treating "redness" and "dark circles under the eyes."

Troxerutin powder

Troxerutin supplier

Troxerutin extract is a good flavonoid that is well recognized for keeping arteries and veins healthy. Our Troxerutin is of pharmaceutical grade and fulfills the highest requirements across the world. Troxerutin bulk powder is a main part of drugs that help with chronic venous insufficiency, hemorrhoids, and difficulties with microcirculation. We observe all FDA, EMA, and ICH guidelines and make sure that every batch is at least 98% pure (HPLC-verified) to make sure that the therapy works the same way every time.

 

Certifications & Global Compliance

Your regulatory success starts with our comprehensive certification portfolio:

  • FDA cGMP certification ensuring US market readiness
  • EMA compliance for European pharmaceutical standards
  • ISO 9001 quality management systems
  • ICH guidelines adherence for international harmonization
  • WHO-cGMP qualification for global market access

Available Documentation:

  • Certificate of Analysis (COA) with each batch
  • Drug Master File (DMF) support for FDA submissions
  • Material Safety Data Sheet (MSDS) for safe handling
  • Stability study reports under ICH conditions

our certifications


Why Choose Our Troxerutin Powder?
Extremely low levels of free rutin and impurities:

Through a five-stage distillation process, we control unreacted free rutin to <0.1%. This not only improves solubility but also completely eliminates the risk of precipitation or stratification during product compounding.

Excellent color consistency and light stability:

The troxerutin produced by Shaanxi Hongda is a uniform pale yellow crystalline powder with excellent thermal stability under light-protected conditions, ensuring that your product's color remains consistent throughout its shelf life.

Tailored for Diverse Formulations

You can take Troxerutin Powder by mouth as tablets or via injection. You may customize it to meet your needs. To have the optimum digestibility, you can adjust the particle size (10–150 µm) or pick varieties that dissolve more easily.

 

Product Specification

Appearance
Crystalline powder
Colour
Yellowish green powder
Solubility
Soluble in water, slightly soluble in waterfree ethanol,practical in soluble in aether
Identification
Must Positive
Clarity of solution
 
Heavy Metal
≤10ppm
Arsenic
≤1ppm
Mercury
≤0.1ppm
Cadmium
≤1ppm
Loss on drying (130℃)
≤4.0%
Ash
≤0.1%
Ethylene oxide
≤1ppm
Assay by UV ( on dry basis)
95.0-102.0%
Main peak (HPLC)
≥80.0%
One peak (HPLC)
≤10%
Single peak (HPLC)
≤5%
Melamine
Negative
Bulk density
≥0.40gm/cc
Tapped density
≥0.60gm/cc
Particle size
100% pass 80 mesh
Microbiological test
 
Total plate count
≤1000cfu/g
Yeast & Mould
≤100cfu/g
E.Coli
Absent
Pseudomonas aeruginosa
Absent

 

The difference between natural troxerutin and synthetic troxerutin

Item
Natural troxerutin
Synthetic troxerutin
Source
Sophora japonica, buckwheat, etc.
Quercetin, rutin and other chemical raw materials
Purity
90–95%
≥98%
Impurity type
Plant pigments, polyphenols
Synthetic by-products
Security
More likely to be accepted
Quality control is required to meet pharmacopoeia standards
Cost
High
Low
Main function
Low-end health products, cosmetics
Medicine, low-end health products

 

Pharmaceutical Applications & Formulation Benefits

Primary Therapeutic Applications:

  • Venous Insufficiency Treatments: Troxerutin powder can enhance circulation support with proven clinical efficacy
  • Hemorrhoid Formulations: Topical and oral applications for comprehensive treatment
  • Vascular Support Therapies: Capillary strengthening and anti-inflammatory properties
  • Edema Management: Effective reduction of fluid retention and swelling

Troxerutin benefits

 

Formulation Advantages:

  • Excellent compressibility for tablet manufacturing
  • Superior dissolution profiles in various pH conditions
  • Stable under standard pharmaceutical processing conditions
  • Compatible with common excipients and active ingredients

Uncompromising Quality Assurance

You want things to stay the same, and we provide you that by following tight guidelines for quality control:

Advanced Analytical Testing:

High-Performance Liquid Chromatography (HPLC) for purity verification

Gas Chromatography-Mass Spectrometry (GC-MS) for impurity profiling

Particle size distribution analysis for formulation consistency

Microbial testing ensuring pharmaceutical safety standards

Batch Traceability: Full paperwork for everything from raw ingredients to finished API, so you may illustrate the full supply chain in your regulatory applications.

Third-Party Audits: Every day, independent auditors inspect our facilities to make sure they always meet international requirements for creating drugs.

laboratory

 

Frequently Asked Questions

1. What certifications do you hold?

Our Troxerutin complies with FDA, EMA, and WHO-GMP standards. Certificates are available upon request.

2. Can I request a custom particle size?

Yes! We offer sizes from 10–150 µm to suit your formulation.

3. How is batch consistency ensured?

Advanced HPLC testing and 12-month stability studies (per ICH Q1A) guarantee uniformity.

4. Do you assist with regulatory filings?

Absolutely. We provide DMF/ASMF documents and audit-ready COAs.

5. What’s your production capacity?

500+ MT annually, with scalable solutions for urgent demands.

 

Ready to Secure Your Troxerutin Supply?

Don't let something you don't know about in the supply chain change how you create medications. Our Troxerutin Powder is of the highest quality and can be shipped anywhere in the globe without fail. This makes sure that the treatment works on your items.

Contact our dedicated procurement team today: duke@hongdaherb.com

our team

 

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