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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.
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%.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Standard preparation— Using Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 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 Assay—Antibiotics 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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1655
Phone Number : 1-301-816-8223