Antares Health Products | Manufacturing, Packaging and Storage of TPGS

About TPGS

PROPERTIES OF TPGS

STABILITY AND SAFETY

MANUFACTURING

REGULATORY INFO

PHARMA/FOOD GRADE

MANUFACTURING, PACKAGING AND STORAGE OF TPGS

Manufacturing The manufacturing facility meets current Good Manufacturing Practices (cGMP) as outlined in ICH Q7A.
Product Grades
Food grade (FG)	The Antares vitamin E TPGS FG exceeds the requirements for use in dietary supplements and foods. Please see the Antares vitamin E TPGS FG product data sheet.
Pharmaceutical Grade (NF)	The Antares vitamin E TPGS NF meets the Current Good Manufacturing Practices (cGMP) requirements for use in pharmaceutical formulations. Please see the Antares vitamin E TPGS FG product data sheet. The Antares vitamin E TPGS NF meets the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG) guidelines for pharmaceutical excipients
Raw materials	Raw materials meet applicable specifications and standards. Raw materials are certified and released by Quality Assurance prior to use in manufacturing.
Manufacturing process	The cGMP compliant manufacturing process: Utilizes ingredients and production equipment which meet kosher requirements. Please see the Antares Kosher certificate. Utilizes ingredients free of BSE/TSE (Bovine Spongiform Encephalopathy/Transmittable Agents of Animal Spongiform Encephalopathy). Please see the Antares The BSE/TSE statement. Utilizes ingredients free and/or removes known allergens. Please see the Antares allergen statement. Removes compounds (such as proteins) that may be changed by genetic modification. Please see the Antares GMO statement. Removes Organic Volatile Impurities (OVI). Please see the Antares OVI statement .
Product release	Antares submits samples from each lot to independent, fully accredited laboratories for chemical and microbial analyses which provides for release of the product for commercial use if it meets specifications and issues the Certificate of Analysis (COA) which along with the Material Safety Data Sheet (MSDS) accompany each shipment.
Package	Antares Vitamin E TPGS FG and NF grades are available in 1 kg and 15 kg in tamper-evident plastic sealed containers. The containers are heat tolerant to at least 50 °C
Shelf-life	Antares Vitamin E TPGS FG and NF grades are labeled with a 4 year shelf -life from the date of manufacturing when stored in the original sealed unopened container

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