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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 D - Microbiological Assay Methods |
§ 436.101 - Solutions.
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(a) Antibiotic assay solutions are prepared as follows (solution numbers 1, 2, 3, 4, and 6 correspond to those used in “Assay Methods of Antibiotics,” D. C. Grove and W. A. Randall, Medical Encyclopedia, Inc., New York, N.Y. (1955), p. 222), which is incorporated by reference. Copies are available from the Medical Encyclopedia Inc., 30 East 60th St., New York, NY 11220, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(1)
Solution 1 (1 percent potassium phosphate buffer, pH 6.0 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 5.95 to 6.05 after sterilization.(2)
Solution 2 (citrate buffer solution pH 6.3 ).Adjust with 10 percent citric acid solution or 10
N sodium hydroxide to yield pH 6.2 to 6.4 after sterilization.(3)
Solution 3 (0.1M potassium phosphate buffer, pH 8.0 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 7.9 to 8.1 after sterilization.(4)
Solution 4 (0.1M potassium phosphate buffer, pH 4.5 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 4.45 to 4.55 after sterilization.(5) [Reserved]
(6)
Solution 6 (10 percent potassium phosphate buffer, pH 6.0 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 5.95 to 6.05 after sterilization.(7)—(9) [Reserved]
(10)
Solution 10 (0.2M potassium phosphate buffer, pH 10.5 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 10.4 to 10.6 after sterilization.(11)
Solution 11 (10 percent potassium phosphate buffer, pH 2.5 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 2.0 to 2.8 after sterilization.(12)
Solution 12 (10 percent potassium phosphate buffer, pH 7.0 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 6.95 to 7.05 after sterilization.(13)
Solution 13 (0.01N methanolic hydrochloric acid ).(14)
Solution 14 (2 percent sodium bicarbonate solution ).Prepare daily.
(15)
Solution 15 (80 percent isopropyl alcohol solution ).(16)
Solution 16 (0.1 M potassium phosphate buffer, pH 7.0 ).Adjust with 18
N phosphoric acid or 10N potassium hydroxide to yield a pH 6.8 to 7.2 after sterilization.(17)
Solution 17 (5 percent methyl alcohol in 1 percent potassium phosphate buffer, pH 6.0 ).(18)
Solution 18 (0.054M sodium phosphate buffer, pH 6.9).