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.
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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.
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.
905:
meet the requirements.
Water, Method I 921:
not more than 8.0%.
921:
not more than 8.0%.
Assay—
Standard preparation—
Using Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425.
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:
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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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
USP35–NF30 Page 4239