(C9H19N)2·C6H10O8 492.65

Isometheptene, galactarate (2:1) (salt).
6-Methylamino-2-methylheptene, tetrahydroxyadipic acid (2:1) (salt) [7492-31-1].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Isometheptene Mucate RS.

Identification, Infrared Absorption 197K.

pH 791: between 6.0 and 7.5, in a solution (1 in 20).

Loss on drying 731— Dry it at 60 for 18 hours: it loses not more than 1.0% of its weight.

Residue on ignition 281: not more than 0.1%.

Residual solvents 467: meets the requirements.

Assay— Transfer about 500 mg of Isometheptene Mucate, accurately weighed, to a 125-mL conical flask. Add 25 mL of water, and swirl to dissolve. Add 45.0 mL of 0.1 N bromine VS, attach a 30-mL separator to the conical flask, and evacuate the system. Stir with a magnetic stirrer for 1 hour. Equilibrate the system to atmospheric pressure. Add 5 mL of hydrochloric acid to the separator, and allow 4 mL of it to enter the conical flask. Add 10 mL of potassium iodide TS to the separator, and allow the contents to pass into the conical flask. Immediately titrate the liberated iodine with 0.1 N sodium thiosulfate VS, adding 3 mL of starch TS as the endpoint is approached. Perform a blank titration (see Residual Titrations under Titrimetry 541). Each mL of 0.1 N sodium thiosulfate is equivalent to 12.32 mg of (C9H19N)2·C6H10O8.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 1188

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