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Last Updated: December 23, 2024

Claims for Patent: 10,626,088


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Summary for Patent: 10,626,088
Title:Determining degradation of 3,4-diaminopyridine
Abstract: The present invention relates to methods of determining the purity of a sample of 3,4-diaminopyridine comprising determining the presence, absence, or amount of a dimer of 3,4-diaminopyridine or a dimer of 3,4-diaminopyridine in the form of a salt, solvate or complex or a combination thereof. The invention also relates to methods of detecting and quantitating degradation in a sample of 3,4-diaminopyridine. Dimers of 3,4-diaminopyridine and methods of making and isolating the same are also provided.
Inventor(s): Schiehser; Guy Alan (Washington Crossing, PA), Shah; Rajendra (Edison, NJ), Zhao; Wenyi (Monroe Township, NJ)
Assignee: JACOBUS PHARMACEUTICAL COMPANY, INC. (Princeton, NJ)
Application Number:15/695,043
Patent Claims: 1. A 3,4-Diaminopyridine dimer that is ##STR00004## or a tautomer thereof; in the form of a salt, solvate, or complex, or a combination thereof.

2. The 3,4-diaminopyridine dimer of claim 1, wherein the salt comprises a sulfate group.

3. The 3,4-diaminopyridine dimer of claim 1, wherein the complex comprises a monohydrate group.

4. The 3,4-diaminopyridine dimer of claim 1, wherein the solvate comprises a monomethanolate group.

5. The 3,4-diaminopyridine dimer of claim 1, wherein salt comprises a sulfate, the solvate comprises a monohydrate, and the complex comprises a monomethanolate.

6. The 3,4-diaminopyridine dimer of claim 1, wherein the 3,4-diaminopyridine dimer is 3,4-diaminopyridine dimer sulfate monohydrate monomethanolate.

7. The dimer of claim 6 in amorphous solid form.

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