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| [Code of Federal Regulations] |
| [Title 21, Volume 5] |
| [CITE: 21CFR331] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE
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| PART 331 | ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE |
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Subpart C - Testing Procedures
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Sec. 331.20 Determination of percent contribution of active ingredients.
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To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active ingredient equal to the amount present in a unit dose of the product into a 250-milliliter (mL) beaker. If wetting is desired, add not more than 5 mL of alcohol (neutralized to an apparent pH of 3.5), and mix to wet the sample thoroughly. Add 70 mL of water, and mix on a magnetic stirrer at 300 +/-30 r.p.m. for 1 minute. Analyze the acid neutralizing capacity of the sample according to the procedure provided in the United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the antacid active ingredient in the total product as follows:
Percent contribution = (Total mEq. Antacid Active Ingredient * 100)/(Total mEq. Antacid Product).
[61 FR 4823, Feb. 8, 1996]
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Sec. 331.21 Test modifications.
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The formulation or mode of administration of certain products may require a modification of the United States Pharmacopeia 23/National Formulary 18 acid neutralizing capacity test. Any proposed modification and the data to support it shall be submitted as a petition under the rules established in § 10.30 of this chapter. All information submitted will be subject to the disclosure rules in part 20 of this chapter.
[61 FR 4823, Feb. 8, 1996]
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Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 39 FR 19874, June 4, 1974, unless otherwise noted.
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