Penicillin G Benzathine Tablets
»Penicillin G Benzathine Tablets contain not less than 90.0percent and not more than 120.0percent 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 3000Penicillin G Units per mL,and filter:the filtrate so obtained responds to the Identificationtest under Penicillin G Benzathine Oral Suspension.
Disintegration á701ñ: 60minutes,simulated gastric fluid TSbeing used in place of water as the test medium.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 8.0%.
Assay—
Standard preparation— Using Penicillin G Potassium RS,prepare as directed for Standard preparationunderIodometric Assay—Antibiotics á425ñ.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer a portion of the powder,accurately weighed,equivalent to about 200,000Penicillin G Units,to a 100-mLvolumetric flask,add 10mLof 1.0Nsodium hydroxide,and mix.Allow to stand for 15minutes,add 10mLof 1.2Nhydrochloric acid,dilute with water to volume,and mix.Pipet 2mLof this solution into a glass-stoppered,125-mLconical flask.
Blank preparation— Transfer an accurately weighed portion of the powdered Tablets remaining from the preparation of the Assay preparation,equivalent to about 200,000Penicillin G Units,to a 100-mLvolumetric flask,dilute with Buffer No.1to volume,and mix.Pipet 2mLof this solution into a glass-stoppered,125-mLconical flask.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ,except in performing the Inactivation and titrationto omit the addition of 1.0Nsodium hydroxide and 1.2Nhydrochloric acid,and in the Blank determinationto use the Blank preparationin 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 Tis the labeled quantity,in Penicillin G Units,in each Tablet,and Dis the concentration,in Penicillin G Units per mL,of the Assay preparationon the basis of the labeled quantity in each Tablet and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1485
Phone Number:1-301-816-8335