Sunflower TPGS™ Food Grade

1 of 2 products in this brand
Sunflower TPGS™ Food Grade is the only commercially available non-GMO TPGS. It is produced exclusively from natural vitamin E derived from sunflower oil.

Ingredient Name: D-alpha tocopheryl Acid Succinate

Functions: Carrier, Emulsifier, Emulsifier, Solubilizer, Vitamin Source, Vitamin Source

Dosage Form: Capsules, Dispersions, Emulsions, Powder & Powder Blends, Soft Gels, Tablets

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Identification & Functionality

Vitamin Type
Animal Feed & Nutrition Functions
Food Ingredients Functions
Pharma & Nutraceuticals Functions
Ingredients
D-alpha tocopheryl Acid Succinate

Features & Benefits

Animal Feed & Nutrition Features

Applications & Uses

Animal Species
Applications
  • Source of water-soluble Vitamin E
  • Emulsifier and solubilizer
  • Enhancer of absorption and bioavailability
  • Product applications include pharmaceuticals, dietary supplements, personal care, cosmetics, animal nutrition products, food, and beverage

Properties

Physical Form
Appearance
Waxy solid, white to light yellow
Soluble in
Water
Typical Properties
ValueUnitsTest Method / Conditions
Colormax. 10GardnerAOAC
Microbiological Values
ValueUnitsTest Method / Conditions
Aerobic Plate Countmax. 10/gFDA BAM
Coliformmax. 5/gFDA BAM
Escherichia ColiNegative /10 gFDA BAM
PseudomonasNegative /10 gFDA BAM
SalmonellaNegative /10 gFDA BAM
Staphylococcus Aureus, CPNegative /10 gFDA BAM
Yeast and Moldmax. 10/gFDA BAM
Nutritional Information (per 100 gm)
ValueUnitsTest Method / Conditions
Ash0
Calcium0g
Carbohydrates12.5g
Cholesterol0g
Copper0g
d-α-tocopherol ¹25mg
Dietary Fiber0
Energy, kcal51kcal
Iron0g
Magnesium0g
Potassium0g
Protein0
Saturated Fat0g
Sodium0g
Sugars0
Total lipid (fat)1g
Vitamin A0
Vitamin C0
Vitamin E¹min. 37250IU
Water0.33g
Zinc0g
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 27ml of a 0.1 N sodium hydroxide solutionNF Monograph
Content Alpha Tocopherolmin. 25%NF Monograph
d-α-Tocopherol (weight basis)25 - 30%
Decompositionmin. 500°C
Flash Point324°C
Free Tocopherolmax. 1.5NF Monograph
Heavy Metalsmax. 10ppmASTM
IdentificationCompliesNF Monograph
Melting Point Range36 - 41°C
Optical Rotationmin. +24.0 °USP <781S>
Residual SolventsCompliesUSP <467>
Specific Gravity (at 45°C)1.06
Vitamin E372 - 447IU/gram
Note

1 The vitamin E activity ranges from 37,250 to 44,700 IU/100 g resulting from the acceptable d-α- tocopherol range of 25 to 30%. Other nutrients are not available in detectable amounts

Regulatory & Compliance

Regulatory Information
  • The United States Pharmacopeia (USP) published a monograph for TPGS in the USP/NF Supplement #9 dated November 15, 1998. The Food and Drug Administration (FDA) includes TPGS in the list of inactive ingredients.
  • In Canada, TPGS is approved as a form of Vitamin E, in the European Community as an Active Pharmaceutical Ingredient (API) and in Japan as a pharmaceutical excipient for oral drug formulations.
  • TPGS meets the Current Good Manufacturing Practice (cGMP) in the manufacturing, processing, packing, or holding of drugs in the FDA Code of Federal Regulations Title 21 Part 210 and the cGMP for finished pharmaceuticals in FDA 21 CFR Part 211. TPGS also meets the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG) guidelines for pharmaceutical excipients.
  • TPGS also meets applicable regulations for microbial limits, heavy metals, and residual solvents.
GMO Statement
  • Antares Health Products does not use Genetically Modified Organisms (GMO) in the manufacturing of Sunflower TPGS™ Food Grade.
  • d-α-tocopheryl succinate contains alpha-tocopherol which is derived from vegetable oil distillate including soybean oil. This raw material is Polymerase Chain Reaction (PCR) negative which indicates absence of DNA and testing with Enzyme-linked Immunosorbent Assay (ELISA) indicates absence of detectable levels of protein.
  • On the basis of data supplied by the manufacturers, the European Food Safety Agency (EFSA) determined that the starting material, the subsequent production process, and the demonstration of low residual protein content makes it unlikely that d-α-tocopherols from soybean sources will trigger a severe allergic reaction in susceptible individuals. Highly refined oils are exempt from Food Allergen Labeling and Consumer Protection Act (FALCPA).
  • Therefore, Antares is of the opinion that TPGS products do not need to be labeled as containing allergen according to FALCPA
Allergen Information
  • The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that the label of a food that contains an ingredient that is or contains protein from a major food allergen declare the presence of the allergen in the manner described by the law. FALCPA defines major allergens as milk, egg, fish, shellfish, tree nuts, wheat, wheat derivatives, gluten, peanuts, and soybeans.
  • Antares Health Products Inc. is of the opinion that all Antares Vitamin E TPGS (TPGS) products do not need to be labeled as containing allergen according to FALCPA.
BSE & TSE Information
  • Antares Vitamin E TPGS (TPGS) is manufactured from synthetic and natural materials which do not contain any bovine or any other animal origin. Additionally, these materials are not derived from specific-risk materials as defined in European Commission Decision 97/534/E.
  • The manufacturing process for TPGS does not use any ingredient of animal origin. TPGS does not come in contact with any animal products during manufacturing, storage, or transportation.
  • Based on the raw materials and the manufacturing process, TPGS is declared free of any animal products and isnot expected to cause transmission of BSE or TSE.
Gras Information
  • Antares Vitamin E TPGS (TPGS) has been self-affirmed as a Generally Recognized As Safe (GRAS) substance.
  • TPGS has a record of safe use in many products including children’s vitamins, food, pharmaceutical, personal care, and animal nutrition products. The United States Pharmacopeia (USP) published a monograph for TPGS in he USP/NF Supplement #9 dated of November 15, 1998. Under the synonym Tocophersolan, TPGS received a unique ingredient identifier (UNII O03S90U1F2) by the joint FDA/USP Substance Registration System (SRS).
Kosher Status

Sunflower TPGS™ Food Gradeis kosher certified.

Residual solvents Statement
  • The manufacturing process for Antares Vitamin E TPGS utilizes two class three solvents as defined by USP <467>.
  • The residual solvent levels are monitored during manufacturing by in process control testing. The acceptancecriterion for each of the class three solvents is less than 0.05% or 500ppm. This level is ten-fold less than the allowable limit for a class three solvent using option one as defined by USP <467>.
cGMP & Food Safety Statement
  • Antares Vitamin E TPGS (TPGS) meets the Current Good Manufacturing Practice (cGMP) in the manufacturing, processing, packing, or holding of drugs in the FDA Code of Federal Regulations Title 21 Part 210 and the cGMP for finished pharmaceuticals in FDA 21 CFR Part 211. TPGS also meets the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG) guidelines for pharmaceutical excipients.
  • cGMP compliance as practiced by Antares exceed and replace the Hazard Analysis and Critical Control Point (HACCP) concept introduced by the FAO/WHO Codex Alimentarius. These include the design of the product, its traceability, release analysis, and the comprehensive documentation of procedures. The quality system is based on risk management for technical systems, production, control of processes, cleaning procedures, and analytical methods. In addition, microbiological monitoring is done on the water used, the production plant, personnel, and the rooms used in loading out the product.
  • All steps of the working procedure are individually documented in Standard Operating Procedures (SOP). In Process Controls (IPC) are carried out to monitor and control production steps. The final products are subjected to analysis of predefined specifications before being released. Essential goals of our cGMP system are the exclusion of deviations in production steps, the final product, and avoidance of biological, chemical, and physicalcontamination.
Halal Status

Sunflower TPGS™ Food Grade is halal certified.

Packaging & Availability

Packaging Information
  • TPGS is available in 500g, 1 kg, 5 kg and 15 kg in tamper-evident plastic sealed containers.
  • The containers are heat tolerant up to 70° C.

Storage & Handling

Shelf Life
4 years
Storage Information

It is recommended that the containers be stored at ambient conditions, closed securely and only opened when necessary.