Packaging and storage—
Preserve in tight containers, in a dry atmosphere.
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.
Dissolution 
711
—
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.
Assay—
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 (CH
4N
2O
2) 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.
Auxiliary Information—
Staff Liaison :
Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1089
Pharmacopeial Forum : Volume No. 29(6) Page 1901
Phone Number : 1-301-816-8320
