Published: May 27, 2020
Austin, TX – Chemi Nutra, is proud to announce that its patented, clinically validated, full FDA GRAS, AlphaSize® A-GPC functional ingredient, now meets the requirements contained in the USP monograph, as published in The Second Supplement to USP 42-NF 37, which became official on December 1, 2019.
The United States Pharmacopeia (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements/ingredients manufactured, distributed and consumed worldwide. These standards are used by regulatory agencies and manufacturers to help ensure these products are of the appropriate identity, strength, quality, purity, and consistency. USP publishes the USP-NF, which is a book of public pharmacopeial standards, published yearly, and monographs for dietary supplements and ingredients are in a separate section of the USP. In 2006, USP acquired the Food Chemicals Codex (FCC), which is a compendium of internationally recognized standards for the purity and identity of food ingredients.
Importantly, USP grade means that AlphaSize® A-GPC fully meets the requirements as contained in the USP monograph for that ingredient and that it is manufactured in a cGMP compliant facility. Accordingly, only AlphaSize® brand A-GPC can be labeled as USP. USP specification consists of a series of tests, procedures for the tests, and exceedingly strict acceptance criteria related to purity and identity – critical components of safety.
AlphaSize® A-GPC is the most remarkable, fully functional, performance benefiting, research validated, specialty ingredient compound in the world. It is a highly bioavailable form of choline, and is a potent precursor to quick biosynthesis of acetylcholine, the body’s primary neurotransmitter, involved in cognitive functions – learning, memory, concentration, recall, and focus, and in physical functions – power, force, strength, and agility. AlphaSize® A-GPC is the premier, all-natural energy ingredient, used widely in powdered, capsule, beverage, bar, gummy, shot, and water enhancer formats, for benefits in mental performance, physical performance, gaming, caffeine replacement, and healthy aging.
“The USP monograph project took us several years to accomplish, and coupled with our FDA GRAS (GRN No. 419) status, and extensive published studies on efficacy, AlphaSize® A-GPC is the only A-GPC ingredient in existence proven pure, unadulterated, safe, and beneficial. Now consumers can look for the ultimate assurance of quality and safety, as USP will now be indicated on finished product labels that bear the AlphaSize® A-GPC brand name”, said Scott Hagerman, president of Chemi Nutra.
Chemi Nutra is the US business unit of parent company Chemi SpA., a privately held pharmaceutical and nutraceutical company based in Milan, Italy. Chemi, with its own US FDA inspected, cGMP certified manufacturing facilities, is best known in the global nutritional arena for its discovery, commercial development, and introduction of SerinAid® PhosphatidylSerine (PS) and AlphaSize® Alpha-Glyceryl Phosphoryl Choline (A-GPC).