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Vitamin E Polyethylene Glycol Succinate

Product Name: Vitamin E Polyethylene Glycol Succinate Cas No.: 9002-96-4 Molecular formula: C33H54O5·(C2H4O)n Appearance: Off-white or yellowish waxy solid Specification: 99% Test Method: HPLC Certifications: ISO9001,KOSHER, HALAL Package specification: 25kg/drum Transportation: Fedex,DHL,UPS, Air, Sea,DDP air,DDP sea Delivery: sufficient inventory, fast and safe transportation OEM/ODM: available Minimum order quantity: sample and small kgs trial order available, commercial order MOQ 25kg

Description

Vitamin E Polyethylene Glycol Succinate – Premium Pharmaceutical Grade Excipient

Shaanxi Nuoyuan Biotech Co., Ltd. delivers pharmaceutical-grade Vitamin E Polyethylene Glycol Succinate (TPGS) manufactured in our 30,000㎡ ISO 9001, Halal, and Kosher certified facility. We have more than 15 years OEM/ODM experience and yearly processing capacity of 20000 tonnes. We could provide TPGS with purity 99% verified by 5 sophisticated HPLC systems.

Our product has a low Critical Micelle Concentration (CMC) of 0.02% w/w and HLB value of 13, which gives better solubilisation performance. Whether it's sophisticated medication delivery networks or cosmetic goods, we have adequate stock to provide quick delivery with DDP choices.

What is Vitamin E Polyethylene Glycol Succinate?

A water-soluble derivative of naturally occurring D-alpha-tocopherol is the product (Tocophersolan/TPGS).Vitamin E succinate is esterified with Polyethylene Glycol 1000 to make it.

The main bioavailability issues with BCS Class II and IV medications are addressed by this non-ionic functional excipient. It is more than just an emulsifier and solubilizer; it is a potent P-glycoprotein (P-gp) inhibitor that overcomes medication resistance.

It is an essential component for pharmaceutical, nutraceutical, and cosmetic applications due to its unique amphiphilic properties. satisfies stringent EP and USP/NF quality standards. FDA Inactive Ingredient Database and FDA GRAS.

Technical Specifications

Product Name

Vitamin E Polyethylene Glycol Succinate(TPGS)

Batch number

/

CAS No.

9002-96-4

Batch quantity

2000kgs

Analysis Item

Specification

Results

Test Method

Appearance

Off-white or yellowish waxy solid

Conforms

Visual

Identification

Meets the requirements

Conforms

ChP<0521>

Solubility in water

20% Min(Clear solution within 3h)

Conforms

Visual

Assay(D-α-tocopherol)

≥ 26.0%

31.1%

ChP<0521>

Acidity

≤ 0.27mL        

0.14mL

ChP2020

Specific Rotation

≥ +24.0˚        

+28.7˚

ChP<0621>

Heavy metals

≤ 10ppm  

< 10ppm

ChP<0821>

Lead (Pb)

≤ 0.5ppm  

< 0.02ppm

ChP<2321>

Arsenic (As)

≤ 1.5ppm  

< 0.01ppm

ChP<2321>

Cadmium (Cd)

≤ 0.5ppm      

< 0.005ppm

ChP<2321>

Mercury (Hg)

≤ 3ppm

< 0.005ppm

ChP<2321>

Residual solvents

Ethyl acetate

≤ 50ppm

Not Detected

ChP<0861>

Ethanol

≤ 200ppm

3ppm

ChP<0861>

Total Plate Count

≤ 1000cfu/g

< 100cfu/g

ChP<1105>

Yeast and Mold

≤ 100cfu/g

< 10cfu/g

ChP<1105>

E.Coli.

Negative

Negative

ChP<1106>

Salmonella

Negative

Negative

ChP<1106>

Staphylococcus aureus

Negative

Conforms

GB 4789.10

Packing&Storage:

Store in tightly closed containers at room temperature.Protected from moisture and pest infestation

Shelf life:

36 months under the conditions above and in its original packaging.

Conclusion:

The product complies with USP43

Key Benefits and Applications

Your formulation challenges require advanced solutions. Vitamin E Polyethylene Glycol Succinate offers multiple functional benefits for your products.

Pharmaceutical Applications:

Developing nanomicellar drug delivery systems for poorly soluble cancer drugs like Paclitaxel or Docetaxel is possible. The chemicals generate stable nanocarriers that circumvent stomach and blood-brain barrier P-gp efflux pumps, increasing bioavailability.

It is used as plasticiser and carrier in solid dispersions and hot melt extrusion (HME) procedures. Its heat stability up to 200°C helps you to increase dissolving rates of crystalline medicines in solid dosage forms.

Cosmetic and Skincare Applications:

The double action of antioxidant and penetration booster will delight you. It prevents oxidation and free radical damage caused by UV and prevents the production of melanin.

It is a non-ionic surfactant with minimal irritation potential and stabilises volatile actives such as Retinol or Vitamin C. Its great emulsifying qualities help to disperse essential oils and poorly soluble vitamins in your compositions.

Applications in Nutraceuticals:

You can improve the absorption of fat soluble vitamins and lipophilic elements. It is cost efficient for softgel and oral supplement formulations because it forms micelles at very low concentrations.

Manufacturing Process & Quality Control

We produce product through a controlled two-step esterification process. First, α-tocopherol reacts with succinic anhydride using triethylamine as catalyst, forming vitamin E succinate intermediate.

Subsequently, the intermediate undergoes PEG esterification at 100°C with acid catalysts. This yields a consistent mixture of mono- and di-esterified TPGS with precise molecular weight distribution.

Our Rigorous Testing Protocol:

Our 5 HPLC systems verify alpha-tocopherol content (25-30%) and purity levels. We monitor acid value to prevent irritation from free succinic acid and hydroxyl value to ensure consistent HLB.

Residual Impurity Testing: GC for ethylene oxide & 1,4-dioxane and ICP-MS for heavy metals. Karl Fisher technique measures water content , important for moisture-sensitive applications.

Every batch undergoes clarity and color assessment. Third-party testing services are available upon request to meet your specific regulatory requirements.

certificate

Storage & Handling Recommendations

Store your goods in a cool, dry place in air-tight containers. Preferably maintain a nitrogen environment since the substance is hygroscopic and will oxidise with time.

This material has a low melting point (38°C) and hence must be handled carefully during processing. Stable to 200°C but take care to check temperature when used in HME or other hot operations.

Its chemical stability in several pH ranges, making it compatible with different solvents such as water, ethanol and vegetable oils. This flexibility makes your product creation easier.

Transportation

transportation

Comprehensive OEM & ODM Solutions

Beyond supplying premium the product, we provide complete customization services for your market needs.

Our team offers custom formulations, packaging design, private labeling, and specification adjustments. We can optimize functional ingredient combinations to help you create competitive products.

From product development and sampling through mass production and shipment, our experienced team provides professional consultation and technical guidance. Our one-stop service platform reduces your costs while improving efficiency.

team

Warehouse & Shipping

Warehouse & Shipping

Exhibitions

Exhibitions


Frequently Asked Questions

Q: How does it improve oral drug bioavailability?

A: It creates micelles that trap lipophilic medicines and inhibits P-gp efflux transporters to prevent the medications from being pumped back into the gut lumen.

Q: Can it be used in Hot Melt Extrusion without degrading?

A: Yes, it is thermally stable up to 200°C, but its 38°C melting point has to be handled with care when feeding.

Q: Is it safe for pharmaceutical and food applications?

A: Certainly. It is on the FDA GRAS list and the FDA Inactive Ingredient Database for a number of dosage formulations .

Q: How should I store the product?

A: Store in airtight containers in cold, dry conditions, especially in a nitrogen atmosphere to avoid oxidation.

Q: How does PEG chain length affect performance?

A: PEG 1000 is industry standard. Shorter or longer chains alter HLB and CMC, significantly changing solubilizing capacity.

Q: What makes your product different?

A: Our 15+ years expertise, 5 HPLC testing systems, and 20,000-ton annual capacity ensure consistent quality with fast delivery from sufficient inventory.

Contact Us

Ready to enhance your formulations with pharmaceutical-grade Vitamin E Polyethylene Glycol Succinate? Contact our team today at sales@nuoyuanbio.com for samples, technical data sheets, or custom solutions.

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