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Title:
ANALYSIS METHOD OF 3-METHYL-1-PHENYL-2-PYRAZOLIN-5-ONE BULK DRUG, TREATMENT FOR AMYOTROPHIC LATERAL SCLEROSIS, INHIBITION OF PROGRESSION OF AMYOTROPHIC LATERAL SCLEROSIS, AND METHOD OF PRODUCING DRUG CONTAINING 3-METHYL-1-PHENYL-2-PYRAZOLIN-5-ONE BULK DRUG
Document Type and Number:
WIPO Patent Application WO/2019/167974
Kind Code:
A1
Abstract:
This method for analyzing the phenylhydrazine content in a 3-methyl-1-phenyl-2-pyrazolin-5-one bulk drug involves: obtaining a first measured value by measuring the phenylhydrazine content of a standard solution that contains phenylhydrazine or a salt thereof, first acidic water and a first water-soluble organic solvent and that exhibits a phenylhydrazine concentration of 0.01-10 μg/mL; obtaining a second measured value by measuring the phenylhydrazine content of a test solution containing the 3-methyl-1-phenyl-2-pyrazolin-5-one bulk drug, second acidic water and a second water-soluble organic solvent; and detecting the phenylhydrazine content in the aforementioned 3-methyl-1-phenyl-2-pyrazolin-5-one bulk drug on the basis of the first measured value and the second measured value. The first acidic water is at least one type selected from hydrochloric acid, an acetic acid aqueous solution, etc., the first water-soluble organic solvent is at least one type selected from acetonitrile, methanol, etc., the second acidic water is at least one type selected from hydrochloric acid, an acetic acid aqueous solution, etc., and the second water-soluble organic solvent is at least one type selected from acetonitrile, methanol, etc.

Inventors:
WAKASUGI, Takeshi (3-2-10 Dosho-machi, Chuo-ku, Osaka-sh, Osaka 05, 〒5418505, JP)
SANO, Aya (3-16-89 Kashima, Yodogawa-ku, Osaka-sh, Osaka 05, 〒5328505, JP)
Application Number:
JP2019/007415
Publication Date:
September 06, 2019
Filing Date:
February 27, 2019
Export Citation:
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Assignee:
MITSUBISHI TANABE PHARMA CORPORATION (3-2-10, Dosho-machi Chuo-ku, Osaka-sh, Osaka 05, 〒5418505, JP)
International Classes:
G01N33/15; A61K31/4152; A61P21/02
Domestic Patent References:
WO2019031495A12019-02-14
Foreign References:
JPH0531523B21993-05-12
JP2008001607A2008-01-10
JP2010077104A2010-04-08
JP2008001606A2008-01-10
JPS63132833A1988-06-04
Attorney, Agent or Firm:
YAMAO, Norihito et al. (AOYAMA & PARTNERS, Umeda Hankyu Bldg. Office Tower 8-1, Kakuda-cho, Kita-ku, Osaka-sh, Osaka 17, 〒5300017, JP)
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