100re / rt

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: 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.