» Lincomycin Injection contains an amount of Lincomycin Hydrochloride in Water for Injection equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of lincomycin (C18H34N2 O6S). It contains benzyl alcohol as a preservative.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mg of lincomycin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.0 and 5.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Lincomycin Hydrochloride.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 600 mg of lincomycin, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 2.0 mL of this solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Lincomycin Hydrochloride. Calculate the quantity, in mg, of lincomycin (C18H34N2O6S) in each mL of the Injection taken by the formula:
0.625(CP / V)(rU / rS)in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
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USP32NF27 Page 2787