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Minocycline for Injection
» Minocycline for Injection is sterile, freeze-dried Minocycline Hydrochloride suitable for parenteral use. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of minocycline (C23H27N3O7).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, protected from light.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
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.
Bacterial endotoxins 85— It contains not more than 1.25 USP Endotoxin Units per mg of minocycline.
pH 791: between 2.0 and 3.5, in a solution containing the equivalent of 10 mg of minocycline per mL.
Water, Method I 921: not more than 3.0%, the Test Preparation being prepared as directed for a hygroscopic specimen.
Particulate matter 788: meets the requirements for small-volume injections.
Limit of epiminocycline— Using the chromatogram of the Assay preparation obtained 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 re is the area response of any peak in the chromatogram of the Assay preparation having a retention time of about 0.86 relative to that of minocycline, and rt is the total area of the responses of all the peaks in the chromatogram: not more than 6.0% of epiminocycline is found.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under 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 0.5 mg 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 0.5 mg of minocycline (C23H27N3O7) per mL.
Procedure— Proceed as directed for Procedure in the Assay under 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 L is the labeled quantity, in mg, of minocycline in the container, or in the volume of constituted solution taken; D is the concentration, in mg per mL, of minocycline in Assay preparation 1 or 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 : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1440
Phone Number : 1-301-816-8223