Guanadrel Sulfate
Guanidine (1,4-dioxaspiro[4.5]dec-2-ylmethyl)-, sulfate (2:1). (1,4-Dioxaspiro[4.5]dec-2-ylmethyl)guanidine sulfate (2:1) ![]() ![]() ![]() » Guanadrel Sulfate contains not less than 97.0 percent and not more than 103.0 percent of (C10H19N3O2)2·H2SO4, calculated on the dried basis.
Packaging and storage
Preserve in well-closed containers.
Identification
The IR absorption spectrum of a mineral oil dispersion of it exhibits maxima only at the same wavelengths as that of a similar preparation of USP Guanadrel Sulfate RS.
Loss on drying
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Residue on ignition
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Heavy metals, Method II
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Assay
Mobile phase
Prepare a filtered and degassed mixture of 530 mL of water and 470 mL of methanol containing about 6.35 g of dl-10-camphorsulfonic acid sodium salt and 0.8 g of ammonium nitrate. Adjust with glacial acetic acid, if necessary, to a pH of between 5.0 and 5.5. Make adjustments if necessary (see System Suitability under Chromatography
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Standard preparation
Dissolve an accurately weighed quantity of USP Guanadrel Sulfate 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 Guanadrel Sulfate, accurately weighed, to a container, add 10.0 mL of Mobile phase, and mix.
Resolution solution
Dissolve suitable quantities of USP Guanadrel Sulfate RS and ethylparaben in Mobile phase to obtain a solution having known concentrations of about 10 mg and 12 mg, respectively, in each mL.
Chromatographic system
(see Chromatography
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Procedure
Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of (C10H19N3O2)2·H2SO4 in the portion of Guanadrel Sulfate taken by the formula:
10C(rU / rS)
in which C is the concentration, in mg per mL, of USP Guanadrel Sulfate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 2541
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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