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Vitamin E TPGS

Specification:25%
Cas No.:9002-96-4
Appearance: Off White or light yellow waxy solid
Lead time: 3-7 Working Days
Package: 25kg/drum, 27 drums/tray
Main Market: European, North America, Asia etc.
Certification: Kosher, Halal, BRC, Organic, ISO9001, ISO22000, etc

Premium Vitamin E TPGS Manufacturer & Supplier | Shaanxi Hongda Phytochemistry

We are your depended on companion in the pharmaceutical and nutraceutical industries, providing you with unrivaled benefits in bioavailability enhancement and system guide. With state-of-the-art manufacturing lines and purification workshops at the level of 100,000, our 20,000-square-meter contemporary factory guarantees that each batch of Vitamin E TPGS is manufactured to fulfil the most exacting international standards such as USP/NF and Ph.Eur monographs. We convey 20+ years of understanding and latest extraction era to deliver steady great answers to main industry worries consisting of low drug solubility and P-glycoprotein efflux resistance. With hongda you've got full traceability, rigorous 1/3 birthday party testing and dedicated technical assistance that speeds up your product improvement agenda even as keeping advanced best control during the manufacturing system.

Product Introduction

The product is a novel water-soluble derivative of natural nutrition E, designed specially for pharmaceutical and nutraceutical packages where superior bioavailability is needed. This amphiphilic molecule combines the antioxidant characteristics of D-alpha-tocopherol and solubilisation residences of polyethylene glycol one thousand succinate. Our pharmaceutical grade substance is an off-white to light yellow waxy solid with excellent surfactant characteristics and an HLB value of 13.2, appropriate for formulating stable oil-in-water emulsions and clear aqueous formulations of lipophilic chemicals.

Third-Party Test Report

Independent Laboratory Verification: All of our product batches are rigorously tested by third-party labs of international renown such as SGS and Eurofins. This gives you complete transparency and regulatory compliance for your quality assurance teams.

Pesticide Residue Analysis: European and US requirements-compliant multi-residue screening. All samples continue to be beneath detection ranges for over 500 not unusual agricultural pesticides, protective pharmaceutical use.

Vitamin E TPGS

Product Specification

Items
Specification
Results
Appearance
Offwhite or yellowish waxy solid
conform
Identification
Meets the requirements
95.69%
Assay(D-alpha tocophenol)
≥ 25%
27.7%
Solubility in water
≥ 20%(clear solution)
conforms
Acidity
≤0.27ml
0.21ml
Specific Rotation
≥+24
+27.8
Heavy Metals
≤10ppm
<10ppm
Cadmium
≤1ppm
<0.01ppm
Arsenic
≤1ppm
<0.040ppm
Lead
≤3ppm
<0.1ppm
Mercury
≤0.1ppm
<0.01ppm
Residual Solvents
Ethyl Acetate ≤3000ppm Ethanol ≤5000ppm
23ppm
86ppm
Total Plate Count
≤1000 cfu/g
<10cfu/g
Yeast & Mold
≤100 cfu/g
<10cfu/g
Salmonella
Negative
Negative
E.Coli
Negative
Negative
Conclusion
The product complies with USP 39

Vitamin E TPGS Advantages

Bioavailability Enhancement: Our substance boosts the oral absorption of BCS Class II and IV molecules by as much as 300% via micelle formation and intestinal permeability enhancement, providing a direct solution to formulation problems with poorly soluble active ingredients.

P-Glycoprotein Inhibition: The chemical inhibits P-gp ATPase activity at low concentrations (as low as 0.02%) and blocks medication efflux, dramatically increasing therapeutic efficacy for substrates like cyclosporine and anti-cancer drugs.

Superior Solubilisation: At a crucial micelle concentration as low as 0.02 wt% it provides stable, optically clear solutions of lipophilic substances such CoQ10, curcumin and omega-3 fatty acids without the need for aggressive co-solvents or high levels of ethanol.

Vitamin E TPGS Application

Pharmaceutical Drug Delivery: Extensively utilized in self-emulsifying drug delivery systems and amorphous solid dispersions for HIV antiretrovirals, immunosuppressants, and oncology therapeutics where overcoming efflux resistance dramatically improves patient outcomes.

Nutraceutical Formulations: Facilitates the development of transparent, water-dispersible supplements including fat-soluble vitamins (D3, K2), cannabinoids (CBD), and botanical extracts, enabling premium positioning with improved absorption claims that appeal to health-conscious customers.

Ophthalmic Solutions: Non-ionic and compatible with corneal pH, it is useful for enhancing residence time and penetration of cyclosporine and other ophthalmological actives through the corneal barrier.

Production Process

Step 1 - Raw Material Selection: Pharmaceutical grade D-alpha-tocopheryl acid succinate and PEG 1000 are obtained from certified suppliers. Incoming quality verification including identity confirmation by HPLC and purity assessment is conducted to ensure consistent starting materials that meet compendial standards.

Step 2 - Esterification Reaction: The response mixture is heated in a nitrogen environment to a temperature of 60-eighty °C. The catalyst is brought below strict manipulate to sell the esterification response among tocopheryl succinate and PEG a thousand to produce the favored amphiphilic shape with negligible free PEG.

Step 3 - Purification: A multi-step procedure consists of vacuum distillation eliminates unreacted components and residual solvents to tiers below ICH limits, delivering pharmaceutical-grade purity with greater than ninety eight% total TPGS content.

Step 4 - Quality Testing: Every manufacturing lot is fully tested for acid price, particular rotation, tocopherol content material (HPLC) and heavy metals and isn't always released until it meets specs.

Step 5 - Packaging: Temperature-controlled filling into pharmaceutical-grade HDPE drums with nitrogen flushing avoids oxidation and every container is batch-unique labelled with complete traceability codes to make sure supply chain transparency.

Hongda's Factory

Why Choose Us?

When you select shaanxi hongda, you select a producer committed on your success. Our manufacturing potential of 3,000 tonnes in line with yr lets in us to offer a dependable continuity of supply for the maximum disturbing tasks. Our Certifications include HALAL, KOSHER, cGMP, FSSC22000, ISO9001 and ISO22000 that validate our compliance to global recognised quality systems. Our SGS-standardized laboratory has analytical capabilities that compare favourably with any testing facility in the world, with HPLC, GC and atomic absorption spectrophotometers. We've 3,000 rectangular meters of inventory warehouses with structured garage zones and we promise 3-7 running day lead times. Extra than merchandise, we offer partnership – technical counsel, troubleshooting resource, and market intelligence from our customer service staff to assist your formulations reap industrial achievement.

 
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OEM/ODM Support

Custom Formulation Development: Our 20-person R&D team works with your scientists to produce custom blends, including Vitamin E TPGS, using design-of-experiments methods and stability testing protocols to optimise ratios for your specific actives.

Particle Engineering Services: Controlled crystallisation and micronization offerings to offer desired particle size distributions in your production system, whether you want unfastened-flowing powders for direct compression or small particles for suspension formulations.

Vitamin E TPGS Package

Our Factory

Hongda's Factory

Our Certifications

Hongda's Certifications

Our Exhibitions

Hongda's Exhibitions

Delivery Methods

Delivery Methods

FAQ

Q: Is this material the only source of Vitamin E in the supplement?

A: Our product has approx. 387 IU/g, even though it works usually as a surfactant and bioavailability enhancer. It's miles fine used as a co-adjuvant to traditional tocopherols, due to the fact the high dosages needed to acquire full vitamin e nutrients can be above the tolerance of the surfactant within the gi tract.

Q: What do I do with the waxy solid form in manufacturing?

A: Soften and regularly homogenise in a warm box or water bath at 50-60°c before sample or processing. This ensures equitable distribution and prevents sampling errors that might undermine the consistency of your formulation.

Q: Is it compatible with the hot melt extrusion process?

A: Yes, but cooling of feed zones to keep away from untimely melting and screw slippage. Its plasticising movement may be useful, but temperature manage throughout the barrel is essential for constant processing.

Contact Us

Ready to enhance your formulation's bioavailability with premium Vitamin E TPGS?

Email: duke@hongdaherb.com​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

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