21 C.F.R. § 357.210   Cholecystokinetic active ingredients.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart C—Cholecystokinetic Drug Products

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§ 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:

 ------------------------------------------------------------------------                                                               Percent                         Fatty acid                          composition------------------------------------------------------------------------Myristic acid..............................................         0.1Palmitic acid..............................................        10.0Palmitoleic acid...........................................         0.1Stearic acid...............................................        13.5Oleic acid.................................................        72.0Linoleic acid..............................................         3.8Linolenic acid.............................................         0.1Arachidic acid.............................................         0.5Behenic acid...............................................         0.2------------------------------------------------------------------------

[54 FR 8321, Feb. 28, 1989]

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