Clindamycin Palmitate Hydrochloride for Oral Solution
»Clindamycin Palmitate Hydrochloride for Oral Solution is a dry mixture of Clindamycin Palmitate Hydrochloride and one or more suitable buffers,colors,diluents,flavors,and preservatives.It contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of clindamycin (C18H33ClN2O5S),the labeled amount being 15mg per mLwhen constituted as directed in the labeling.
Packaging and storage— Preserve in tight containers.
Uniformity of dosage units á905ñ—
FORSOLIDPACKAGEDINSINGLE-UNITCONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 2.5and 5.0,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 3.0%.
Assay—
Internal standard solution and Standard preparation—Prepare as directed in the Assayunder Clindamycin Palmitate Hydrochloride.
Assay preparation— Constitute the Clindamycin Palmitate Hydrochloride for Oral Solution as directed in the labeling,and transfer 5.0mLof the constituted solution to a glass-stoppered,15-mLconical centrifuge tube.Add 5.0mLof Internal standard solutionand 1mLof sodium carbonate solution (3in 10),and proceed as directed for Standard preparation,in the Assayunder Clindamycin Palmitate Hydrochloride,beginning with “Insert the stopper,shake vigorously.”
Chromatographic system— Proceed as directed in the Assayunder Clindamycin Palmitate Hydrochloride.
Procedure— Proceed as directed in the Assayunder Clindamycin Palmitate Hydrochloride.Calculate the quantity,in mg,of C18H33ClN2O5Sin each mLof the solution constituted from Clindamycin Palmitate Hydrochloride for Oral Solution taken by the formula:
(F/1000)(WS/V)(RU/RS),
in which Vis the volume,in mL,of constituted solution from Clindamycin Palmitate Hydrochloride for Oral Solution taken and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 495
Phone Number:1-301-816-8335
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