Isometheptene Mucate
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
(C9H19N)2.C6H10O8 492.65
Isometheptene, galactarate (2:1) (salt);
6-Methylamino-2-methylheptene, tetrahydroxyadipic acid (2:1) (salt) CAS RN®: 7492-31-1; UNII: 8O120FDS6P.
1 DEFINITION
Isometheptene Mucate contains NLT 99.0% and NMT 103.0% of isometheptene mucate [(C9H19N)2.C6H10O8], calculated on the dried basis.
2 IDENTIFICATION
Change to read:
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)
3 ASSAY
Procedure
Sample: 500 mg of Isometheptene Mucate
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Residual titration
Titrant: 0.1 N bromine VS
Back-titrant: 0.1 N sodium thiosulfate VS
Endpoint detection: Visual
Analysis:
Sample: Sample
Transfer the Sample to a 125-mL conical flask. Add 25 mL of water, and swirl to dissolve. Add 45.0 mL of Titrant. Attach a 30-mL separator to the conical flask, and evacuate the system. Stir with a magnetic stirrer for 1 h. 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 Back-titrant, adding 3 mL of starch TS as the endpoint is approached. Perform a blank titration. Each mL of 0.1 N sodium thiosulfate is equivalent to 12.32 mg of isometheptene mucate [(C9H19N)2.C6H10O8 ]. Acceptance criteria: 99.0%–103.0% on the dried basis
4 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.1%
5 SPECIFIC TESTS
pH 〈791〉
Sample solution: A solution of Isometheptene Mucate in water (1 in 20)
Acceptance criteria: 6.0–7.5
Loss on Drying 〈731〉
Analysis: Dry at 60° for 18 h.
Acceptance criteria: NMT 1.0%
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers.
USP Reference Standards 〈11〉
USP Isometheptene Mucate RS
