§ 436.102 - Culture media.

(a) Ingredients. Use ingredients that conform to the standards, if any, prescribed by the U.S.P. or N.F. In lieu of preparing the media from the individual ingredients specified, they may be made from dehydrated mixtures that, when reconstituted with distilled water, have the same composition as such media. Minor modifications of the individual ingredients specified in this section are permissible if the resulting media possess growth-promoting properties at least equal to the media described.

(b) Description of media. Medium numbers 1, 2, 3, 4, 5, 8, 9, 10, 11, and 13 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. 220, which is incorporated by reference. Copies are available from Medical Encyclopedia Inc., 30 East 60th St., New York, NY, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. Medium numbers 18 through 21 correspond to those used in “Outline of Details for Official Microbiological Assays of Antibiotics,” A. Kirshbaum and B. Arret, “Journal of Pharmaceutical Sciences,” vol. 56, No. 4, April 1967, p. 512, which is incorporated by reference. Copies are available from the American Pharmaceutical Association, 2215 Constitution Ave. NW., Washington, DC 20037, or available for inspection at the Office of the Federal Register (see address in this paragraph).

(1) Medium 1.

(2) Medium 2.

(3) Medium 3.

(4) Medium 4.

(5) Medium 5. Medium 5 is the same as medium 2, except adjust the final pH to 7.8 to 8.0 after sterilization.

(6)-(7) [Reserved]

(8) Medium 8. Medium 8 is the same as medium 2, except adjust the final pH to 5.8 to 6.0 after sterilization.

(9) Medium 9.

(10) Medium 10. Medium 10 is the same as medium 9, except:

(11) Medium 11. Medium 11 is the same as medium 1, except adjust the final pH to 7.8 to 8.0 after sterilization.

(12) [Reserved]

(13) Medium 13.

(14)-(18) [Reserved]

(19) Medium 19.

(20)-(31) [Reserved]

(32) Medium 32. Prepare as medium 1, except add 300 milligrams of hydrated manganese sulfate (MnSO4·H2O) to each liter of medium.

(33) Medium 33. Use medium 1, sterilized and cooled to 50° C. Aseptically add sufficient sterile sodium novobiocin solution to give a final concentration of 10 micrograms of novobiocin activity per milliliter of medium. Sterile sodium novobiocin solution is prepared by filtering a solution containing 2.5 milligrams of novobiocin per milliliter of distilled water through a membrane filter of 0.22-micron porosity.

(34) Medium 34.

(35) Medium 35. Same as medium 34, except add 17.0 grams of agar to each liter of medium.

(36) Medium 36.

Pancreatic digest of casein15.0 gm.Papaic digest of soybean5.0 gm.Sodium chloride5.0 gm.Agar15.0 gm.Distilled water, q.s1,000.0 ml.pH 7.3 after sterilization

(37) Medium 37.

(38) Medium 38.