» Hydroxyurea Capsules contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydroxyurea (CH4N2O2).
Packaging and storage Preserve in tight containers, in a dry atmosphere.
USP Reference standards 11
Identification Transfer a portion of the Capsule contents, equivalent to about 30 mg of hydroxyurea, to a suitable centrifuge tube, and add 10 mL of anhydrous methanol. Mix, and centrifuge for 3 minutes. Transfer 1.0 mL of the clear supernatant to a mortar containing 500 mg of potassium bromide, triturate to a homogeneous blend, dry in a vacuum desiccator at 60 for 3 hours, and prepare a suitable disk: the IR absorption spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydroxyurea RS.
Medium: water; 500 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure Determine the amount of CH4N2O2 dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Tolerances Not less than 80% (Q) of the labeled amount of CH4N2O2 is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Solution A, Solution B, Mobile phase, Resolution solution, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Hydroxyurea.
Assay preparation Remove, as completely as possible, the contents of not fewer than 20 Capsules. Grind to a fine powder, and transfer an accurately weighed portion of the powder, equivalent to about 200 mg of hydroxyurea, to a 500-mL volumetric flask. Add about 300 mL of Mobile phase, sonicate for 10 minutes, stir with the aid of a magnetic stirrer for 30 minutes, sonicate for an additional 10 minutes, and dilute as necessary with Mobile phase to volume. Filter a portion of the resulting solution, discarding the first 2 mL of the filtrate.
Procedure Proceed as directed for Procedure in the Assay under Hydroxyurea. Calculate the quantity, in mg, of hydroxyurea (CH4N2O2) in the portion of Capsules taken by the formula:
500C(rU / rS)in which C is the concentration, in mg per mL, of USP Hydroxyurea RS in the Standard preparation; and rU and rS are the peak responses for the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3458Pharmacopeial Forum: Volume No. 29(6) Page 1901