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PART 141-TESTS AND METHODS OF ASSAY FOR ANTIBIOTIC DRUGS [REVISED]

CODIFICATION: Prior to revision, Part 141 was amended in the following respects during the period covered by this Supplement: Sec.

the petri dish and calculate therefrom the number of viable microorganisms per gram of suppository. [Reg., Dec. 26, 1946, effective Jan. 1, 1947, 12 F.R. 4]

§ 141.19 Buffered crystalline penicillin. Proceed as directed in §§ 141.1, 141.2, 141.3, 141.4, 141.5, and 141,6. [Reg., Jan. 8, 1947, effective Jan. 14, 1947, 12 F.R. 208]

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(e) Preparation of plates.

CODIFICATION: § 141.1 (e) was amended in the following respects, by Regulation, Acting Administrator, Jan. 8, 1947, effective Jan. 14, 1947, 12 F.R. 208:

1. The words, "and stored for 24 hours at room temperature" were inserted in the 14th sentence between the figure "37° C." and the word "with".

2. The 16th sentence was amended to read "Incubate 24 hours at 37° C. and store for 24 hours at room temperature".

§ 141.18 Penicillin vaginal suppositories(a) Potency. Proceed as directed in § 141.1 except paragraph (g) (3) of that section and in lieu of the directions in paragraph (d) prepare sample as follows:

Place 5 suppositories in a separatory funnel containing 150 ml of peroxide free ether. Shake the separatory funnel vigorously to bring about complete mixing of the material with the ether. Shake with a 25 ml portion of 1% phosphate buffer at pH 6.0. Remove the buffer layer and repeat the extraction with three 25 ml quantities of buffer. Combine all extracts and make the proper estimated dilutions in 1% phosphate buffer at pH 6.0. The average potency of the suppository is satisfactory if it contains not less than 85% of the number of units it is represented to contain.

(b) Moisture. Proceed directed as § 141.7 (c) using one suppository.

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(c) Microorganism count. Use four suppositories and place approximately one fourth of each into each of four sterile, tared test tubes. Determine weight of sample in each tube. Melt at 37° C. and add suficient penicillinase to inactivate the penicillin in the sample. Mix thoroughly. Incubate for one hour at 37° C. Mix thoroughly and transfer the contents of each tube to 25 ml of nutrient agar prepared as directed in § 141.1 (b) (1) cooled to approximately 48° C. Mix thoroughly and pour into sterile petri dishes. Allow to harden, invert and incubate at 37° C. for 48 hours. Count the number of colonies appearing on

141.5

141.6

Sodium penicillin, calcium penicillin, potassium penicillin; potency. Sodium penicillin, calcium penicillin, potassium penicillin; sterility. Sodium penicillin, calcium penicillin, potassium penicillin; pyrogens.

Sodium penicillin, calcium penicillin, potassium penicillin; toxicity. Sodium penicillin, calcium penicillin, potassium penicillin; moisture, clarity, crystallinity and heat stability.

Sodium penicillin, calcium penicillin, potassium penicillin; penicillin X.

Penicillin in oil and wax.

Penicillin ointment.

Tablets buffered penicillin.

Penicillin with aluminum hydrox

Penicillin troches.

Penicillin dental cones.

Penicillin for surface application.

141.7

141.8

141.9

141.11

ide gel.

141.12

141.13

141.14

Penicillin with vasoconstrictor.

141.15

141.16

Tablets alum precipitated penicillin.

141.17

Penicillin sulfonamide powder.

141.18

141.19

Buffered crystalline penicillin.

141.20

Capsules buffered penicillin with

141.21

141.22

141.23

Penicillin vaginal suppositories.

pectin hydrolysate.

Crystalline penicillin tablets.
Penicillin bougies.

Crystalline penicillin and epine-
phrine in oil.

141.101 Streptomycin sulphate, streptomycin hydrochloride, streptomycin phosphate, streptomycin trihydrochloride calcium chloride; potency.

141.102 Streptomycin sulphate, streptomycin hydrochloride, streptomycin phosphate, streptomycin trihydrochloride calcium chloride; sterility.

141.103 Streptomycin sulphate, streptomycin hydrochloride, streptomycin phosphate, streptomycin trihydrochloride calcium chloride; toxicity.

141.104 Streptomycin sulphate, streptomycin hydrochloride, streptomycin phosphate, streptomycin trihydrochloride calcium chloride; pyrogens.

141.105 Streptomycin sulphate, streptomycin hydrochloride, streptomycin phosphate, streptomycin trihydrochloride calcium chloride; histamine.

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§ 141.1

Sodium penicillin, calcium penicillin, potassium penicillin; potency-(a) Cylinders (cups). Use stainless steel cylinders with an outside diameter of 8 mm. (±0.1 mm.), an inside diameter of 6 mm. (±0.1 mm.), and a length of 10 mm. (±0.1 mm.).

(b) Culture media. Use ingredients that conform to the standards prescribed by the U. S. P. or N. F. (1) Make nutrient agar for the seed layer and for carrying the test organism as follows:

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ents specified in paragraph (b) (1), (2), and (3) of this section are permissible if the resulting media possess growth promoting properties at least equal to the media described.

(c) Working standard. Keep the working standard (obtained from the Food and Drug Administration) in tightly stoppered vials, which in turn are kept in larger stoppered tubes containing anhydrous calcium sulfate, constantly in the refrigerator at 15° C. (59° F.) or below. Weigh out carefully in an atmosphere of 50 percent relative humidity or less between 4 and 5 mg. of the working standard and dilute with sterile 1% phosphate buffer (pH 6.0) to make a stock solution of any convenient concentration. Keep this solution at a temperature of about 10° C., and use for one day only. From this stock solution make appropriate working dilutions.

(d) Preparation of sample. Dissolve aseptically, in sterile distilled water, the sample to be tested to make an appropriate stock solution.

(e) Preparation of plates. Add 21 ml. of agar to each Petri dish (20 x 100 mm.). Distribute the agar evenly in the plates and allow it to harden. Use the plates the same day they are prepared. The test organism is Staphylococcus aureus (F. D. A. 209-P) or (9144) American Type Culture Collection. Maintain the test organism on agar slants and transfer to a fresh agar slant about once a week. Prepare an inoculum for the plates by transferring the culture from the agar slant into broth and incubate at 37° C. From 16 to 24 hours thereafter add 2.0 ml. of this broth culture to each 100 ml. of agar which has been melted and cooled to 48° C. Mix the culture and agar thoroughly and add 4 ml. to each of the plates containing the 21 ml. of the uninoculated agar. Tilt the plates back and forth to spread the inoculated agar evenly over the surface. Porcelain covers glazed on the outside are used. four cylinders on the agar surface so that they are at approximately 90° intervals on a 2.8 cm. radius. In so placing the cylinders drop them from a height of 1⁄2 inch, using a mechanical guide or device. A suspension of the test organism may be used in place of the broth culture described above in preparing the inoculum for the seeding of plates. Prepare such suspension as follows: Wash the organisms from an agar slant which has been incubated for 24 hours at 37° C. and stored for 24 hours at room temperature

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