21 CFR § 357.210
Cholecystokinetic active ingredients
June 25, 2020
The active ingredient of the product consists of any of the following when used within the specified concentration and dosage form established for each ingredient:
(a) 50-percent aqueous emulsion of corn oil.
(b) Hydrogenated soybean oil in a suitable, water-dispersible powder. The hydrogenated soybean oil is food-grade, partially hydrogenated with a melting point of 41 to 43.5 °C, an iodine value of 65 to 69, and a fatty acid composition as follows:
Open Table
Fatty acid | Percent composition |
---|---|
Myristic acid | 0.1 |
Palmitic acid | 10.0 |
Palmitoleic acid | 0.1 |
Stearic acid | 13.5 |
Oleic acid | 72.0 |
Linoleic acid | 3.8 |
Linolenic acid | 0.1 |
Arachidic acid | 0.5 |
Behenic acid | 0.2 |
[54 FR 8321, Feb. 28, 1989]