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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 436 - TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS |
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Subpart C - Biological Test Methods |
§ 436.35 - Depressor substances test.
Latest version.
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Proceed as directed in the USP XX depressor substances test. Prepare the sample test solution as follows: For each antibiotic listed in the table below, select the appropriate diluent and test dose (concentration and volume). If the product is packaged for dispensing and is in a combination
package with a container of diluent, dilute the product as directed in the labeling. Antibiotic Diluent 1 Concentration of test solution 2 Volume of test solution to be injected 3 Bleomycin sulfate 4 4 0.51.0 Capreomycin sulfate 4 3.0 1.0 Chlortetracycline hydrochloride 3 5.0 .6 Clindamycin phosphate 4 5.0 1.0 Daunorubicin hydrochloride 4 1.5 1.0 Dihydrostreptomycin sulfate 4 3.0 1.0 Doxorubicin hydrochloride 4 1.5 1.0 Doxycycline hyclate 4 5.0 1.0 Lincomycin hydrochloride monohydrate 4 3.0 1.0 Minocycline hydrochloride 4 5.0 .6 Plicamycin 3 0.050 1.0 Mitomycin 4 0.050 1.0 Oxytetracycline 5 3 5.0 .6 Oxytetracycline hydrochloride 4 5.0 .6 Rolitetracycline 4 5.0 .6 Rolitetracycline nitrate 4 5.0 .6 Sodium colistimethate 4 3.0 1.6 Spectinomycin hydrochloride 4 15.0 1.0 Streptomycin sulfate 4 3.0 1.0 Tetracycline hydrochloride 4 5.0 .6 Tetracycline phosphate 5 3 5.0 .6 Vidarabine monohydrate 5 4 1.0 1.0 1 Diluent number as listed in sec. 436.31(b).2 Milligrams of activity per milliliter.3 Milliliters per kilogram of body weight.4 The concentration of the test solution is expressed in units per milliliter in lieu of milligrams of activity per milliliter.5 To prepare the test solution, proceed as directed in the individual section of the antibiotic drug regulation in this chapter for the antibiotic to be tested.