Mitsubishi Tanabe Pharma Corporation

Takeshi Wakasugi

Aya Sano

A method of analyzing phenylhydrazine content in a 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient includes obtaining a first measured value by measuring a phenylhydrazine content of a standard solution including phenylhydrazine or a salt thereof, a first acidic water and a first water-soluble organic solvent and having a phenylhydrazine concentration of 0.01 μg/mL to 10 μg/mL, obtaining a second measured value by measuring a phenylhydrazine content in a sample solution including a 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient, a second acidic water and a second water-soluble organic solvent, and detecting a phenylhydrazine content in a 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient based on the first measured value and second measured value. The first acidic water includes hydrochloric acid, the first water-soluble organic solvent is acetonitrile and/or methanol, the second acidic water includes hydrochloric acid, and the second water-soluble organic solvent is acetonitrile and/or methanol.

Analysis method of 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient, treatment for amyotrophic lateral sclerosis, inhibition of progression of amyotrophic lateral sclerosis, and method of producing medicament containing 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient

A method of analyzing phenylhydrazine content in a 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient includes obtaining a first measured value by measuring a phenylhydrazine content of a standard solution including phenylhydrazine or a salt thereof, a first acidic water and a first water-soluble organic solvent and having a phenylhydrazine concentration of 0.01 &#x3bc;g/mL to 10 &#x3bc;g/mL, obtaining a second measured value by measuring a phenylhydrazine content in a sample solution including a 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient, a second acidic water and a second water-soluble organic solvent, and detecting a phenylhydrazine content in a 3-methyl-1-phenyl-2-pyrazolin-5-one active pharmaceutical ingredient based on the first measured value and second measured value. The first acidic water is hydrochloric acid, and/or an aqueous acetic acid solution, the first water-soluble organic solvent is acetonitrile and/or methanol, the second acidic water is hydrochloric acid, and/or an aqueous acetic acid solution, and the second water-soluble organic solvent is acetonitrile and/or methanol.

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Osaka, Japan

Takeshi Wakasugi