» Xylose contains not less than 98.0 percent and not more than 102.0 percent of C5H10O5, calculated on the dried basis.
Packaging and storage Preserve in tight containers at controlled room temperature.
USP Reference standards 11
Color of solution A freshly prepared solution (1 in 10) is clear and colorless.
B: 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.
Specific rotation 781S: between +18.2 and +19.4.
Test solution: 100 mg per mL, in 0.012 N ammonium hydroxide.
Loss on drying 731 Dry 2 g to 5 g at a pressure not exceeding 50 mm of mercury at 60 to constant weight, a current of dried air being passed through the oven during the drying period to remove water vapor: it loses not more than 0.1% of its weight.
Residue on ignition 281: not more than 0.05%.
Iron 241 Dissolve 2.0 g in 45 mL of water, and add 2 mL of hydrochloric acid: the limit is 5 ppm.
Heavy metals 231 Dissolve 2.0 g in water to make 25 mL of solution: the limit is 0.001%.
Chromatographic purity Use the chromatogram of the Assay preparation, obtained as directed in the Assay. Calculate the percentage of each individual impurity, excluding any solvent peaks, in the portion of Xylose taken:
100(ri / rS)in which ri is the response of each individual impurity; and rS is the sum of all of the responses in the chromatogram: not more than 1.0% of any individual impurity is found, and the sum of all individual impurities found is not more than 2.0%.
Mobile phase Use a degassed mixture of acetonitrile and water (75:25).
System suitability solution Prepare a solution in Mobile phase, containing about 10 mg of USP Xylose RS and 0.2 mg of USP Fructose RS per mL.
Standard preparation Dissolve an accurately weighed quantity of USP Xylose RS in Mobile phase to obtain a solution having a known concentration of about 10 mg per mL.
Assay preparation Transfer about 100 mg of Xylose, accurately weighed, to a 10-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 192-nm detector and a 4.6-mm × 15-cm column that contains packing L8. The column temperature is maintained at 30, and the flow rate is about 2 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the resolution, R, between the xylose and fructose peaks is not less than 2.0. The relative standard deviation for replicate injections is not more than 2.0%.
Procedure Separately inject equal volumes (about 25 µL) of the Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C5H10O6, in the portion of Xylose taken by the formula:
10C(rU / rS)in which C is the concentration, in mg per mL, of USP Xylose RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 5052Pharmacopeial Forum: Volume No. 34(4) Page 995