Lincomycin Hydrochloride Soluble Powder
»Lincomycin Hydrochloride Soluble Powder contains an amount of Lincomycin Hydrochloride equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of lincomycin (C18H34N2O6S).
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that it is for veterinary use only.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ: not more than 6.0%.
Assay—
Mobile phase andChromatographic system— Proceed as directed in the Assayunder Lincomycin Hydrochloride.
Standard preparation— Dissolve an accurately weighed quantity of USP Lincomycin Hydrochloride RSin Mobile phaseto obtain a solution having a known concentration of about 1.2mg per mL.
Assay preparation— Remove as completely as possible the contents of not fewer than 5containers.Weigh and mix the combined contents,and transfer an accurately weighed portion of the Soluble Powder,equivalent to about 400mg of lincomycin (C18H34N2O6S),to a 100-mLvolumetric flask.Add about 80mLof Mobile phase,and swirl to dissolve.Dilute with Mobile phaseto volume,and mix.Transfer 25.0mLof this solution to a second 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed in the Assayunder Lincomycin Hydrochloride.Calculate the quantity,in mg,of lincomycin (C18H34N2O6S)in the portion of Soluble Powder taken by the formula:
0.4CP(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1134
Pharmacopeial Forum:Volume No.28(1)Page 73
Phone Number:1-301-816-8178