Lincomycin Injection
»Lincomycin Injection contains an amount of Lincomycin Hydrochloride in Water for Injection equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of lincomycin (C18H34N2O6S).It contains benzyl alcohol as a preservative.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mg of lincomycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pHá791ñ: between 3.0and 5.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Lincomycin Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 600mg of lincomycin,to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Transfer 2.0mLof this solution to a 25-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Lincomycin Hydrochloride.Calculate the quantity,in mg,of lincomycin (C18H34N2O6S)in each mLof the Injection taken by the formula:
0.625(CP/V)(rU/rS),
in which Vis the volume,in mL,of Injection 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 1134
Phone Number:1-301-816-8335