Lincomycin Hydrochloride Syrup
(Current titlenot to change until June 1,2005)
Monograph title changeto become official June 1,2005
See Lincomycin Oral Solution
»Lincomycin Hydrochloride Syrup contains an amount of lincomycin hydrochloride (C18H34N2O6S·HCl·H2O)equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of lincomycin (C18H34N2O6S),and one or more suitable colors,flavors,preservatives,and sweeteners in water.
Packaging and storage
Preserve in tight containers.
Uniformity of dosage units á905ñ
FORSYRUP PACKAGED IN SINGLE-UNIT CONTAINERS:
meets the requirements.
Deliverable volume á698ñ:
meets the requirements.
pHá791ñ:
between 3and 5.5.
Assay
Mobile phase,Standard preparation,andChromatographic system
Proceed as directed in the Assayunder Lincomycin Hydrochloride.
Assay preparation
Transfer an accurately measured volume of Syrup,freshly mixed and free of air bubbles,equivalent to about 100mg of lincomycin,to a suitable container.Add 0.5mLof sodium carbonate solution (3in 10),and swirl for 30seconds,noting that a precipitate forms.Add 1.0mLof 0.2Nsodium hydroxide,swirl for 30seconds,add 10.0mLof chloroform,and shake by mechanical means for 10minutes.Centrifuge,and remove the upper aqueous layer by suction.Transfer 1.0mLof the clear chloroform layer to a suitable container,and evaporate under a stream of nitrogen to dryness.Add 10.0mLof Mobile phaseto the residue,and dissolve by swirling,sonicating if necessary.
Procedure
Proceed as directed in the Assayunder Lincomycin Hydrochloride,recording the chromatogram over a period seven times the retention time of lincomycin.Calculate the quantity,in mg,of lincomycin (C18H34N2O6S)in each mLof the Syrup taken by the formula:
(CP/10V)(rU/rS),
in which Vis the volume,in mL,of Syrup 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
USP28NF23Page 1135
Pharmacopeial Forum:Volume No.28(2)Page 313
Phone Number:1-301-816-8335
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