C19H24N2O·H2SO4 394.49
-[2-(Dimethylamino)propyl]--phenylbenzeneacetamide sulfate [60-46-8].

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.

Identification—

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%.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (VET05) Veterinary Drugs 05

USP29–NF24 Page 139

Phone Number : 1-301-816-8178