Packaging and storage
Preserve in tight containers.
Labeling
Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification
B:
It responds to the tests for
Sodium 191.
pH 791:
between 5.0 and 7.5, in a solution containing 60 mg per mL.
Loss on drying 731
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60
for 3 hours: it loses not more than 1.5% of its weight.
Assay
Mobile phase, Resolution solution, Standard preparation, and Chromatographic system
Proceed as directed in the
Assay under
Penicillin G Potassium.
Assay preparation
Transfer about 5 mg of Penicillin G Sodium, accurately weighed, to a 50-mL volumetric flask, add about 45 mL of water, and shake to dissolve. Dilute with water to volume, and mix.
Procedure
Proceed as directed in the
Assay under
Penicillin G Potassium. Calculate the potency, in Penicillin G Units per mg, of Penicillin G Sodium taken by the formula:
(PWS / WU)(rU / rS),
in which
WU is the weight of Penicillin G Sodium taken to prepare the
Assay preparation, and the other terms are as defined therein.
Auxiliary Information
Staff Liaison :
Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29NF24 Page 1667
Pharmacopeial Forum : Volume No. 27(1) Page 1814
Phone Number : 1-301-816-8223