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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 90.0 percent and not more than 120.0 percent of the labeled amount of clindamycin (C18H33ClN2O5S), the labeled amount being 15 mg per mL when constituted as directed in the labeling.
Packaging and storage— Preserve in tight containers.
Uniformity of dosage units 905—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 2.5 and 5.0, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 3.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Internal standard solution and Standard preparation—Prepare as directed in the Assay under Clindamycin Palmitate Hydrochloride.
Assay preparation— Constitute the Clindamycin Palmitate Hydrochloride for Oral Solution as directed in the labeling, and transfer 5.0 mL of the constituted solution to a glass-stoppered, 15-mL conical centrifuge tube. Add 5.0 mL of Internal standard solution and 1 mL of sodium carbonate solution (3 in 10), and proceed as directed for Standard preparation, in the Assay under Clindamycin Palmitate Hydrochloride, beginning with “Insert the stopper, shake vigorously.”
Chromatographic system— Proceed as directed in the Assay under Clindamycin Palmitate Hydrochloride.
Procedure— Proceed as directed in the Assay under Clindamycin Palmitate Hydrochloride. Calculate the quantity, in mg, of C18H33ClN2O5S in each mL of the solution constituted from Clindamycin Palmitate Hydrochloride for Oral Solution taken by the formula:
(F / 1000)(WS / V)(RU / RS),
in which V is 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 : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 538
Phone Number : 1-301-816-8223