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FEDERAL
VOLUME 13

REGISTER
1934

NlTV

NUMBER 201

Washington, Thursday, October 14, 1948
10.0-ml. aliquot of this solution by the following method:
Chapter l--Food and Drug Adminis ii Reagentsa Sodium nitrite solu tion. Dissolve 0.1 gm. of sodium nitrite tration, Federal Security Agency in 100 ml. distilled water. Prepare fresh P art 141T ests and M ethods of A ssay solution every other day.
for A ntibiotic D rugs b Ammonium sulfamate solution.
Dissolve 0.5 gm. of ammonium sulfamate P art 146C ertification of B atches of in 100 ml. distilled water.
P e n ic il l in - or S treptomycin -C on
c N- 1-naphthyl -ethylenediamine taining D rugs solution. Dissolve 0.1 gm. of N- 1-naph MISCELLANEOUS AMENDMENTS
thyl -ethylenediamine dihydrochloride By virtue of the authority vested in the in 100 ml. distilled water. Prepare fresh Federal Security Administrator by the solution every other day.
provisions of section 507 of the Tederal iii Standard curve. Prepare a stand Food, Drug, and Cosmetic Act 52 Stat. ard stock solution containing 275.5 ml. of 1040, 1055, as amended by 59 Stat. 463 procaine hydrochloride U. 3. P. in a and 61 Stat. 11; 21 U. S. C., Sup. 357, liter of distilled water. A standard the regulations for tests and methods of working solution containing 2.755 mg.
assay of antibiotic drugs 12 F. R. 2215;" per liter is prepared by diluting 10.0 ml.
13 F. R. 439, 2475, 3969, 4186 and cer of the -standard stock solution to a liter tification of batches of penicillinor with distilled water. Each milliliter of streptomycin-containing drugs 12 F. R. the standard working solution is equiva 2231, 4369, 8723; 13 F. R. 436, 1087, 2291, lent to 6 units of procaine penicillin.
2475, 2950, 3969, 4186, 5152 are amended Transfer, respectively, 2.0, 4.0, 6.0, 8.0, as indicated below:
and 10.0 ml. of the standard working 1.
Part 141 is amended by adding thesolution and 10.0 ml. of distilled water to following new section:
each of six 25-ml. volumetric flasks. Add 141.32 Procaine penicillin and "buff 8.0, 6.0, 4.0, and 2.0 ml. of water to the ered crystalline penicillin for aqueous first four flasks, respectively, to give each injectiona Potency, sterility, mois a volume of 10.0 ml. To each flask add ture, pyrogens, toxicity, pH. Proceed as 0.5 ml. of 4N HC1, 1.0 ml. of the sodium nitrite solution, 1.0 ml. of the ammonium directed in 141.29.
b Buffered crystalline penicillin con sulfamate solution, and 1.0 ml. of the tent1 Preparation of sample. Add N-1-naphthyl -ethylenediamine solu 20 ml. of distilled water to the contents tion, with mixing after each addition.
of a vial of the sample and shake well. Make each flask to a volume of 25 ml.
Centrifuge, decant, and centrifuge the with distilled water. Read the percent decanted liquid to obtain 12 to 15 ml. of light transmission of the colored solu tions using a 2.0 cm. cell and a 550 u clear solution.
2 Iodometric assay for total peni filter in a suitable photoelectric color cillin. Dilute a 5.0-ml. aliquot of the imeter. The instrument is balanced so clear solution prepared in accordance that the zero concentration reads 100%
with subparagraph 1 of this paragraph light transmission. Prepare a standard to 50 ml. with 1% phosphate buffer at curve on semilog paper, plotting the per pH 6.0. Determine the total quantity of cent light transmission on the loga penicillin in a 2.0-ml. aliquot of this so rithmic ordinate scale and the concen lution by the iodometric assay procedure tration as units of procaine penicillin on the abscissa.
described in 141.5 e.
iv Procedure. By means of a volu 3 Colorimetric determination of pro caine penicillin, i Transfer a 10.0-ml. metric pipette transfer to a 25-ml. volu aliquot of the solution prepared in submetric flask 10.0 ml. of the solution pre paragraph 2 of this paragraph to a pared in subparagraph 3 i of this 1-liter volumetric flask and make to vol paragraph. Add 0.5 ml. of 4N HC1, 1.0
ume with distilled water. Determine the ml. of the sodium nitrite solution, 1.0 ml.
quantity of procaine penicillin in a Continued on next page
TITLE 21 FOOD AND DRUGS

CONTENTS
Agriculture Department
Pase
Proposed rule making:
Milk handling, Lima, Ohio, area. 6020
Peas, canned, field and blackeye; U. S. standards for grades Corr.__________________ 6019
Sugar consumption require ments, quotas, and quota de ficits, 1949________________ 6019
Alien Property, Office of
Notices:
Vesting orders, etc.:
Epp, Leonhard____________
Klein, Karl_______________
Mosle, Dorothea C__.______
Pieroni, Louis_____________
Vahlkamp, Minnie________

6041
6042
6042
6042
6041

Fédéral Communications Commission
Notices :
International Convention for Safety of Life at Sea, 1948;
notice to U. S. shipowners, ship radio station licensees, etc 1___
6034
Schedule of hearings, October 1948 to June 1949_________ 6035
Federal Power Commission
Notices:
Hearings, etc.:
Atlantic Seaboard Corp____
Foley, G. F_______________
Lone Star Gas Co_________
Mesabi Pipe Line Co_______
Mesabi Pipe Line Co. and Trunkline Gas Supply Co__
Northwestern Public Service Co------- -------------

6032
6033
6032
6033
6033
6033

Fish and Wildlife Service
Rules and regulations:
Railroad Valley National Wild life Refuge, Nevada; hunting-

6018

Food and Drug Administration
Proposed rule making :
Bread and related products;
definitions and standards of identity__________________ 6024
6015