Pure Luteolin Powder

Certified cGMP/ISO Manufacturer for Anti-Inflammatory, Anticancer & Neuroprotective Drug Development

Are you searching for a trustworthy source of pure Luteolin powder that meets the rigorous standards of pharmaceutical manufacturing? Our Luteolin powder boasts a purity level exceeding 98% and fully complies with all relevant legal and regulatory standards. This pharmaceutical-grade raw material is derived from non-GMO *Sophora japonica* trees, and our production processes strictly adhere to cGMP guidelines. As a potent natural flavonoid capable of crossing the blood-brain barrier (BBB), Luteolin offers precise regulatory effects on microglia. It not only neutralizes free radicals but also inhibits the excessive release of inflammatory factors at the source. The pure Luteolin supplied by Shaanxi Hongda is specifically designed for brands seeking high bioavailability and minimal residue levels, empowering you to gain a competitive edge in the markets for cognitive function restoration and allergy response modulation. Whether pharmaceutical manufacturers are dedicated to developing treatments for cancer, inflammation, or neuronal damage, our Luteolin powder ensures a precise and sufficient supply of raw materials for every production batch.

Key Product Highlights

• HPLC checks the purity of medicines between 98% and 99.9%.
• cGMP, ISO 9001, Kosher, and Halal certifications make sure that everyone follows the rules.
• Made for large-scale research and manufacture of drug mixtures
• All the paperwork you need, such the COA, HPLC, MSDS, and stability data

Why Pharmaceutical Companies Choose Our Pure Luteolin Powder

Shaanxi Hongda not only supplies standard Luteolin powder but has also developed "Solubilization-Grade Micronization Technology." By optimizing crystal morphology through physical means, we have increased the dispersion rate of Luteolin in lipid-based systems and mixed solvents by 35%. If you are developing liposomal capsules or functional sprays, our raw materials can significantly reduce the risk of precipitation.

Proven Track Record: Our Pure Luteolin has helped people submit IND and NDA applications in a wide variety of therapeutic areas for more than 25 years. Big pharmaceutical companies and other leaders in the area have employed it.

Technical Expertise: Our team of formulation scientists is here to help you with every part of the creation process. We make sure that luteolin is introduced to your medicinal formulations in the best way possible, from the earliest viability tests to industrial scale-up.

Regulatory Excellence: The FDA and other international agencies review our plants on a regular basis to make sure they meet cGMP standards. Because of this, your supply chain will fulfill the highest criteria for creating drugs.

Innovation Partnership: We don't only provide you good raw materials. We also collaborate with your R&D teams to make bioavailability better, get the formulation parameters just right, and fix frequent difficulties that come up during development.

Product Specification

Pharmaceutical Applications & BenefitsTargeted Therapeutic Uses

1. Anti-Inflammatory Drugs: It stops COX-2 (IC50 ≤5 µM) and TNF-α, however the right quantity is critical.

2. Oncology Adjuvants: Helps models of triple-negative breast cancer go through apoptosis (in vitro EC50: 20 µM).

3. Neuroprotective Formulations: It passes past the blood-brain barrier (logP: 2.8) to lower stress that makes you respond.

Why Formulators Choose Us

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Raw Material Control: We maintain deep collaborative partnerships with large-scale Sophora japonica cultivation bases, ensuring that pesticide residue control for our raw materials begins right at the cultivation stage.

Flexible Processing: We can tailor the drying profile of our extracts to suit your specific final dosage form, thereby adjusting the powder's bulk density to directly align with the operational speed of your filling equipment.

Rapid Response: We provide raw HPLC chromatograms within 24 hours and fully support comparative testing by independent third-party laboratories (such as Eurofins or SGS).

Quality Assurance You Can Trust

Our ISO 9001/GMP-certified facilities utilize:

• Chromatography: HPLC-PDA for purity, GC-MS for residual solvents.
• Stability Testing: 6-month accelerated studies (40°C/75% RH) with impurity tracking.
• Supply Chain Audits: FDA-compliant raw material sourcing with redundant suppliers.

Flexible Packaging & Logistics

• Bulk Orders: 1kg to 1,000kg in vacuum-sealed bags with oxygen absorbers.
• Clinical Trial Kits: 10g-100g aliquots (GDP-compliant cold chain shipping).
• Global Compliance: CITES, EXIM, and REACH documentation included.

FAQs

1. What certifications ensure your Pure Luteolin Powder meets pharma standards?

We are happy to have the following certifications: GMP (WHO), ISO 9001, and Kosher/Halal. There are guidelines in the USP-NF and EP concerning how third-party reviews should be done.

2. How is the ≥98% purity verified?

Shimadzu LC-20 HPLC-PDA figures out how much luteolin is in a sample and does GC-MS tests on 50 or more liquids (but not more than 0.1 percent of the total).

3. Can I access stability data for formulation planning?

Yes. We provide 6/12/24-month stability reports (ICH Q1A guidelines) covering degradation products under stress conditions.

4. Is your luteolin natural or synthetic?

100% plant-derived from Sophora japonica. Advanced crystallization ensures ±1% batch-to-batch variance.

10. Are CoA and DMF files available for regulatory submissions?

Absolutely. We supply full CTD modules, including Drug Master File references for FDA/EMA filings.

Request Professional Samples & Pricing

Ready to evaluate our premium Pure Luteolin Powder for your next breakthrough therapeutic? We offer complimentary 10g evaluation samples to pre-qualified pharmaceutical companies working on legitimate drug development projects.

Contact our pharmaceutical sales team: duke@hongdaherb.com