» Aminopentamide Sulfate contains not less than 95.0 percent and not more than 103.0 percent of C19H24 N2O·H2SO4.
Packaging and storage Preserve in tight containers, and store at controlled room temperature.
Labeling Label it to indicate that it is for veterinary use only.
USP Reference standards 11
USP Aminopentamide Sulfate RS.
Clarity and color of solution Dissolve 0.5 g in 10 mL of water: the solution is clear and colorless.
B: It meets the requirements of the tests for Sulfate 191.
Melting range 741: between 179 and 186.
pH 791: between 1.2 and 3.0, in a solution (2.5 in 100).
Loss on drying 731 Dry it at 105 for 4 hours: it loses not more than 4.4% of its weight.
Residue on ignition 281: not more than 0.5%.
Assay Dissolve about 500 mg of Aminopentamide Sulfate, accurately weighed, in 100 mL of dimethylformamide in a suitable container. Add 5 drops of thymol blue TS, and titrate with 0.1 N lithium methoxide VS in toluene to a deep blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N lithium methoxide is equivalent to 19.72 mg of C19H24N2O·H2SO4.
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USP32NF27 Page 1521Pharmacopeial Forum: Volume No. 30(4) Page 1163