U.S. PHARMACOPEIA

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Lincomycin Hydrochloride Soluble Powder
» Lincomycin Hydrochloride Soluble Powder contains an amount of Lincomycin Hydrochloride equivalent to not less than 90.0 percent and not more than 110.0 percent 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 6.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase and Chromatographic system— Proceed as directed in the Assay under Lincomycin Hydrochloride.
Standard preparation— Dissolve an accurately weighed quantity of USP Lincomycin Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 1.2 mg per mL.
Assay preparation— Remove as completely as possible the contents of not fewer than 5 containers. Weigh and mix the combined contents, and transfer an accurately weighed portion of the Soluble Powder, equivalent to about 400 mg of lincomycin (C18H34N2O6S), to a 100-mL volumetric flask. Add about 80 mL of Mobile phase, and swirl to dissolve. Dilute with Mobile phase to volume, and mix. Transfer 25.0 mL of this solution to a second 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed in the Assay under 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., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 1257
Pharmacopeial Forum : Volume No. 28(1) Page 73
Phone Number : 1-301-816-8178