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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