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4872

RULES AND REGULATIONS

8. Section 141.32 b 3
i is 11. Section 141.34 a is amended to amended to read as follows:
read as follows:
3 Colorimetric determination of pro 141.34 Procaine penicillin and crys caine penicillin, f Transfer a 2.0-ml. talline penicillin in oil a Total po aliquot of the solution prepared inr subtency. Proceed as directed in 141.27
paragraph 2 of this paragraph to a a or by the iodometric assay procedure 50-ml. volumetric flask and add 8.0 ml. described in 141.5 e, using in the lat of distilled water. Determine the quan ter procedure a 0.5-ml. aliquot of the tity of procaine penicillin in this solution solution prepared as follows: Introduce by the following method:
1 ml. of the well-shaken sample, by means of a hypodermic syringe, into a 9. Section 141.32 b 3 iii is 50-ml. volumetric flask. Make to 50 ml.
amended to read as follows:
with chloroform-absolute alcohol 1+1
iii Standard curve. Prepare a stand solvent and shake well.
ard solution containing 27.55 mg. of pro 12. Section 141.34 b is amended to caine hydrochloride U. S. P. in a liter of distilled vwater each milliliter of the read as follows:
standard solution is equivalent to 60 units b Crystalline penicillin. Proceed as of procaine penicillin. Transfer, re directed in 141.32 b, except prepare spectively, 1.0, 2.0, 3.0, 4.0, and 5.0 ml. of the sample as follows: Introduce 1 ini.
the standard solution and 5.0 ml. of dis of the well-shaken sample, by means of tilled water to each of six 25-ml. volu a hypodermic syringe, into a 30-ml.
metric flasks. Add 4.0, 3.0, 2.0, and 1.0 centrifuge tube equipped with a screw ml. of water to the first four flasks, re cap. Add 10.0 ml. of chloroform and spectively, to give each a volume of 5.0 10.0 ml. of a 20% sodium sulfate solution, ml. To each flask add 0.5 ml. of 4N HC1, shake well for about 1 minute and centri 1.0 ml. of the sodium nitrite solution, 1.0 fuge to obtain a clear upper layer.
ml. of the ammonium sulfamate, and 1.0
13. Section 141.34 c is amended to ml. of the N- 1-naphthyl -ethylenediamine solution, with mixing after each read as follows:
addition. Make each flask to volume of c Procaine penicillin. The differ 50 ml. with distilled water. Read the ence between the total penicillin as de percent light transmission of the colored termined by paragraph a of this sec solutions using a 2.0-cm. cell and a 550 tion-and the crystalline penicillin as de m /u filter in a suitable photoelectric termined by paragraph b Of this sec colorimeter. The instrument is balanced tion represents the amount of procaine so that the zero concentration reads penicillin present.
100% light transmission. Prepare a 14. In 141.108 Dihydrostreptomycin standard curve on semilog paper, plotting sulfate, crystalline dihydrostreptomycin the percent light transmission on the log sulfate, subparagraph Grams 1 ii of para Citric acid__ ______________________ 52.9
arithmic ordinate scale and the con graph b Content of streptomycin sul Sodium hydroxide p e lle ts________
28.25
centration of units of procaine penicillin fate or streptomycin hydrochloride, is Sodium citrate_____ !------------------------388.0
on the abscissa.
amended by changing the figures Make up to 4000 ml. w ith distilled water.
10. Section 141.32 b 3 iv is 0.05% and 0.5 to 0.25% and 2.5, respectively.
4. Section 141.22 a is amended to amended to read as follows:
15. Section 141.108 b 2 and 3 are read as follows:
iv Procedure. By means of a volu amended to read as follows:
metric pipette transfer to a 50-ml.
volu 141.22 Penicillin bougies a Po flask 2.0 ml. of the solution pre 2
Standard curve. Prepare a stock tency. Proceed as directed in 141.9 a . metric pared in subparagraph 2 of this para aqueous solution of the Food and Drug 5. Section 141.24 a is amended to graph. Add 0.5 ml. of 4N HC1, 1.0 ml. Administration working standard con of the sodium nitrite solution, 1.0 ml. of taining 1.0 mg. of streptomycin base per read as follows:
the ammonium sulfamate solution, and milliliter. Store this standard solution 141.24 Aluminum penicillin a 1.0 ml. of the N- 1-naphthyl-ethylenein the refrigerator and use for no longer Potency. Proceed as directed in 141.1 diamine solution with mixing after each than 2 weeks. Transfer 1.0, 2.0, 3.0, 4.0, a, using citrate buffer as prepared in addition. Make to 50 ml. with distilled and 5.0 ml. of this standard solution and 141.16 a in lieu of phosphate buffer.
water. Set the colorimeter at 100% 10 ml. of distilled water to each of six 6. Section 141.29 a is amended to light transmission with the 0% concen 25-ml. volumetric flasks. Add 9.0, 8.0, tration blank as directed above and ob 7.0, and 6.0 ml. of distilled water to the read as follows:
tain the percent light transmission of first four tubes, respectively, to give each 141.29 Procaine penicillin for aque the sample. The concentration obtained a total volume of 10 ml. To each add 2.0
ous injection a Potency. Proceed as directly from the standard curve cor ml. of IN NaOH and then heat the flasks directed in 141.1, using a 50% acetoneresponding to the percent light trans in a boiling water bath for 10 minutes.
mission of the sample equals the concen Cool the flasks in ice water for 3 minutes water solution to dissolve the sample.
tration of procaine penicillin in 2 ml. of and acidify the solutions with 2.0 ml. of 7. Section 141.32 b 1 is amended the solution prepared in subparagraph 1.2N HC1. To each flask add 5.0 ml. of to read as follows:
2 of this paragraph. The content of 0.25% ferric chloride reagent, make to 141.32 Procaine penicillin and buf buffered crystalline penicillin in 1.0 ml. volume with distilled water, and mix fered crystalline penicillin for aqueous of the suspension is equal to the differ thoroughly. Transfer the colored solu ence between the total number of units tions to 2.0-cm. absorption cells and injection.
b Buffered crystalline penicillin con of penicillin in 2.0 ml. of the solution as measure the percent light transmission by subparagraph 2 of this at 550 m/i in a suitable photoelectric tent 1 Preparation of sample. Add determined paragraph and the total number of units colorimeter. Set the colorimeter at 100 %
the indicated amount of distilled water of procaine penicillin in 2.0 ml. of this light transmission for the zero concen to the contents of a vial of the Sample same solution as determined above, mul tration and then obtain the percent light and shake well. Withdraw 1.0 ml. o f the tiplied by 50. The content of buffered transmission of the sample. Prepare a suspension with a hypodermic syringe crystalline penicillin in the batch is sat standard curve on semilog paper, plot and place in a 15-ml. centrifuge tube. isfactory when determined by the method ting the percent light transmission on Add 9.1 ml. of 20% sodium sulfate solu described in this paragraph if it is not the logarithmic ordinate scale and the tion, shake well, and centrifuge to ob less than 85% of that which it is repre concentration of streptomycin base on sented to contain.
tain a clear solution.
the abscissa.

regulations for tests and methods of assay of antibiotic and antibiotic-con taining drugs- 12 P. R. 2215, 7997; 13
P. R. 436, 2475, 4186, 6015, 6749; 14 F. R.
886 and certification of antibiotic and antibiotic-containing drugs 12 P. R.
2231; 13 P. R. 2475, 2950; 14 P. R. 886, 1519 are amended as indicated below:
1. In 141.7 a the seventh sentence Is changed to read as follows:
- 141.7 Penicillin in oil and waxa Potency. The sample may also be prepared by transferring aseptically 1.0 ml. of the penicillin in oil and wax to a blending jar containing 100 ml.
of 1% phosphate buffer at pH
6.0.
2. Section 141.9 a is amended by changing the fifth and sixth sentences to read as follows:
141.9 Penicillin tablets a Po tency. The sample may also be prepared as follows: Place 12 tablets in a blending jar and add thereto ap proximately 200 ml. of a 500-ml. quantity of 1% phosphate buffer at pH 6.0. After blending for 1 minute with a high-speed blender add the remainder of the 500
ml. of buffer.
3. Section 141.16 a is amended to read as follows:
14L16 Tablets aluminum penicil lin a Potency. Proceed as directed in 141.9 a, using citrate buffer at pH
6.3 in lieu of phosphate buffer. The citrate buffer is of the following composi tion: