Hydroxyurea Capsules
»Hydroxyurea Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of hydroxyurea (CH4N2O2).
Packaging and storage—
Preserve in tight containers,in a dry atmosphere.
Identification—
Transfer a portion of the Capsule contents,equivalent to about 30mg of hydroxyurea,to a suitable centrifuge tube,and add 10mLof anhydrous methanol.Mix,and centrifuge for 3minutes.Transfer 1.0mLof the clear supernatant to a mortar containing 500mg of potassium bromide,triturate to a homogeneous blend,dry in a vacuum desiccator at 60
for 3hours,and prepare a suitable disk:the IRabsorption spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydroxyurea RS.
for 3hours,and prepare a suitable disk:the IRabsorption spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydroxyurea RS.
Dissolution á711ñ—
Medium:
water;500mL.
Apparatus 2:
50rpm.
Time:
30minutes.
Procedure—
Determine the amount of CH4N2O2dissolved,employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances—
Not less than 80%(Q)of the labeled amount of CH4N2O2is dissolved in 30minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
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 20Capsules.Grind to a fine powder,and transfer an accurately weighed portion of the powder,equivalent to about 200mg of hydroxyurea,to a 500-mLvolumetric flask.Add about 300mLof Mobile phase,sonicate for 10minutes,stir with the aid of a magnetic stirrer for 30minutes,sonicate for an additional 10minutes,and dilute as necessary with Mobile phase to volume.Filter a portion of the resulting solution,discarding the first 2mLof 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 Cis the concentration,in mg per mL,of USP Hydroxyurea RSin the Standard preparation;and rUand rSare the peak responses for the Assay preparation and the Standard preparation,respectively.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 980
Pharmacopeial Forum:Volume No.29(6)Page 1901
Phone Number:1-301-816-8389