Packaging and storage
Preserve in Containers for Injections
as described under Injections 1
. Maintain in the frozen state.
It meets the requirements for Labeling
under Injections 1
. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
The retention time of the main vancomycin peak in the chromatogram of Test preparation A
obtained as directed in the test for Chromatographic purity
corresponds to that in the chromatogram of a similar preparation of USP Vancomycin Hydrochloride RS
It meets the requirements when tested as directed for Membrane Filtration
under Test for Sterility of the Product to be Examined
, except to use water instead of Diluting Fluid A
Allow a container of Injection to thaw, and mix the solution. Dilute a portion of the solution with water to obtain a solution containing 0.5 mg of vancomycin per mL, heat at 65
for 24 hours, and allow to cool.
Test preparation A
Allow a container of Injection to thaw, and mix the solution.
Test preparation B
Transfer 2.0 mL of Test preparation A to a 50-mL volumetric flask, dilute with Solution A to volume, and mix.
Proceed as directed for Procedure
in the test for Chromatographic purity
under Vancomycin Hydrochloride
. Calculate the percentage of vancomycin B in the specimen taken by the formula:
2500rB / (25rB + rA),
in which the terms are as defined therein: not less than 88% of vancomycin B is found.
Calculate the percentage of any individual peak, other than the main peak, by the formula:
100rAi / (25rB + rA),
in which the terms are as defined therein: not more than 4% of any peak other than the main peak is found.
It meets the requirements under Injections 1
Proceed as directed for Vancomycin under AntibioticsMicrobial Assays 81
, preparing the Test Dilution
as follows. Allow a container of Injection to thaw, and mix the solution. Dilute an accurately measured portion of this solution quantitatively with Buffer No. 4
to yield a Test Dilution
having a concentration assumed to be equal to that of the median dose of the Standard.
: Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29NF24 Page 2240
: Volume No. 27(4) Page 2784
Phone Number : 1-301-816-8223