Penicillin G Benzathine Tablets
» Penicillin G Benzathine Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of penicillin G.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
Identification Shake a suitable quantity of finely powdered Tablets with methanol to obtain a solution containing about 3000 Penicillin G Units per mL, and filter: the filtrate so obtained responds to the Identification test under Penicillin G Benzathine Oral Suspension.
Disintegration 701: 60 minutes, simulated gastric fluid TS being used in place of water as the test medium.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 8.0%.
Standard preparation Using Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric AssayAntibiotics 425.
Assay preparation Weigh and finely powder not less than 20 Tablets. Transfer a portion of the powder, accurately weighed, equivalent to about 200,000 Penicillin G Units, to a 100-mL volumetric flask, add 10 mL of 1.0 N sodium hydroxide, and mix. Allow to stand for 15 minutes, add 10 mL of 1.2 N hydrochloric acid, dilute with water to volume, and mix. Pipet 2 mL of this solution into a glass-stoppered, 125-mL conical flask.
Blank preparation Transfer an accurately weighed portion of the powdered Tablets remaining from the preparation of the Assay preparation, equivalent to about 200,000 Penicillin G Units, to a 100-mL volumetric flask, dilute with Buffer No. 1 to volume, and mix. Pipet 2 mL of this solution into a glass-stoppered, 125-mL conical flask.
Procedure Proceed as directed for Procedure under Iodometric AssayAntibiotics 425, except in performing the Inactivation and titration to omit the addition of 1.0 N sodium hydroxide and 1.2 N hydrochloric acid, and in the Blank determination to use the Blank preparation in place of the Assay preparation. Calculate the quantity, in Penicillin G Units, in the portion of Tablets taken by the formula:
(T / 2D)(F)(B I)in which T is the labeled quantity, in Penicillin G Units, in each Tablet, and D is the concentration, in Penicillin G Units per mL, of the Assay preparation on the basis of the labeled quantity in each Tablet and the extent of dilution.
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USP35NF30 Page 4239