personal care

regulatory

The Food and Drug Administration (FDA) defines maltodextrins, (C₆H₁₀O₅)_n•H₂O, CAS Reg. No. 9050-36-6, as non-sweet, nutritive saccharide polymers that consist of D-glucose units linked primarily by alpha-1-4 bonds, having a DE less than 20. They are prepared as a white powder or concentrated solution by partial hydrolysis of corn starch with safe and suitable acids and/or enzymes. Maltodextrins are generally recognized as safe (GRAS) ingredients at levels consistent with current good manufacturing practices (21 CFR 184.1444). The INCI nomenclature is “maltodextrin.”

Corn syrup solids, (C₆H₁₀O₅)_n•H₂O, CAS Reg. No. 68131-37-3, are defined by the FDA as dried glucose syrup (21 CFR 168.121) in which the reducing sugar content is 20 DE or higher. Corn syrup solids are generally recognized as safe (GRAS) ingredients at levels consistent with current good manufacturing practices (21 CFR 184.1865).

Corn starch is a Generally Recognized as Safe (GRAS) ingredient. It can also be purchased as NF grade meeting the requirements for the NF monograph for Corn Starch.

GPC NF and USP starches and modified starches are manufactured under current GMPs to meet the requirements set forth in the specific NF or USP monograph for that starch. INCI nomenclature is specific to the particular starch manufactured.

Drug Master File numbers for MALTRIN^® and starch products are available upon request.