Minocycline for Injection
»Minocycline for Injection is sterile,freeze-dried Minocycline Hydrochloride suitable for parenteral use.It contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of minocycline (C23H27N3O7).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,protected from light.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
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.
Bacterial endotoxins á85ñ— It contains not more than 1.25USP Endotoxin Units per mg of minocycline.
pHá791ñ: between 2.0and 3.5,in a solution containing the equivalent of 10mg of minocycline per mL.
Water,Method Iá921ñ: not more than 3.0%,the Test Preparationbeing prepared as directed for a hygroscopic specimen.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Limit of epiminocycline— Using the chromatogram of the Assay preparationobtained as directed in the Assay,calculate the percentage of epiminocycline in the portion of Minocycline for Injection taken by the formula:
100re/rt,
in which reis the area response of any peak in the chromatogram of the Assay preparationhaving a retention time of about 0.86relative to that of minocycline,and rtis the total area of the responses of all the peaks in the chromatogram:not more than 6.0%of epiminocycline is found.
Other requirements— It meets the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.
Assay—
Mobile phase,Standard preparation,Resolution solution,andChromatographic system— Proceed as directed in the Assayunder Minocycline Hydrochloride.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Minocycline for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Withdraw all of the withdrawable contents,using a hypodermic needle and syringe,and dilute quantitatively with water to obtain a solution containing the equivalent of about 0.5mg of minocycline (C23H27N3O7)per mL.
Assay preparation 2 (where the label states the quantity of minocycline in a given volume of constituted solution)—Constitute Minocycline for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured portion of the constituted solution quantitatively with water to obtain a solution containing the equivalent of about 0.5mg of minocycline (C23H27N3O7)per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Minocycline Hydrochloride.Calculate the quantity,in mg,of minocycline (C23H27N3O7)in the container,or in the portion of constituted solution taken by the formula:
0.001C(L/D)(rU/rS),
in which Lis the labeled quantity,in mg,of minocycline in the container,or in the volume of constituted solution taken;Dis the concentration,in mg per mL,of minocycline in Assay preparation 1or in Assay preparation 2,on the basis of the labeled quantity in the container,or in the portion of constituted solution taken,respectively,and the extent of dilution;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 1299
Phone Number:1-301-816-8335
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