4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-[6-(phenoxyacetyl)amino]-, monopotassium salt, [2
S-(2
,5
,6
)]-.
Monopotassium (2
S,5
R,6
R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
[
132-98-9].
Packaging and storage—
Preserve in tight containers.
Labeling—
Label it to indicate that it is to be used in the manufacture of nonparenteral drugs only.
Identification—
B:
It responds to the flame test for
Potassium 
191
.
pH 791:
between 4.0 and 7.5, in a solution containing 30 mg per mL.
Loss on drying 731—
Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60
for 3 hours: it loses not more than 1.5% of its weight.
Phenoxyacetic acid—
Test solution—
Dissolve an accurately weighed quantity of Penicillin V Potassium quantitatively in Diluent to obtain a solution containing 20.0 mg per mL. [NOTE—Use this solution on the day prepared.]
Procedure—
Proceed as directed for
Procedure in the test for
Phenoxyacetic acid under
Penicillin V. Calculate the percentage of phenoxyacetic acid in the portion of Penicillin V Potassium taken by the formula:
5C(rU / rS),
in which
C is the concentration, in mg per mL, of phenoxyacetic acid in the
Standard solution, and
rU and
rS are the phenoxyacetic acid peak responses obtained from the
Test solution and the
Standard solution, respectively. Not more than 0.5% is found.
Limit of p-hydroxypenicillin V—
Using the chromatogram of the
Assay preparation obtained as directed in the
Assay, calculate the percentage of
p-hydroxypenicillin V in the portion of Penicillin V Potassium taken by the formula:
100rp / rU,
in which
rp is the
p-hydroxypenicillin V peak response, and
rU is the sum of the
p-hydroxypenicillin V and penicillin V peak responses: not more than 5.0% is found.
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—
Proceed as directed in the
Assay under
Penicillin V.
Assay preparation—
Transfer about 125 mg of Penicillin V Potassium, accurately weighed, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Penicillin V. Calculate the quantity, in USP Penicillin V Units, in each mg of the Penicillin V Potassium taken by the formula:
50(CP / WU)(rU / rS),
in which
WU is the weight, in mg, of Penicillin V Potassium taken to prepare the
Assay preparation, and the other terms are as defined therein.
;)