21 C.F.R. § 357.210

Current through October 31, 2024

Section 357.210 - Cholecystokinetic active ingredients

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:

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

21 C.F.R. §357.210

54 FR 8321, Feb. 28, 1989