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 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.

The invention relates to a salt of 3-methyl-1-phenyl-2-pyrazolin-5-one (edaravone), wherein the salt is 3-methyl-1-phenyl-2-pyrazolin-5-one napadisylate or 3-methyl-1-phenyl-2-pyrazolin-5-one hemi-napadisylate. These napadisylate salts of edaravone are easy to manufacture and dissolve more rapidly in water than the free edaravone base. In addition, the edaravone salts of the present invention are very stable and easy to handle. The invention also relates to a pharmaceutical composition comprising the aforementioned edaravone salt and to a method of preparing such edaravone salt.

A plastic container has superior storage stability for pharmaceutical ingredients exhibiting a high affinity to plastic and can be mass-produced at low cost. The container has a bag body formed into a bag shape by a sheet member with a storage part on the inside thereof, and a tubular port member attached to the bag body, wherein one end of the tubular port member communicates with the storage part and an opening part of the other end is exposed outside of the bag body. The sheet member is formed from two or more layers including a base resin layer and an innermost layer formed from an amorphous polymer, as a main component, formed by polymerizing at least one type of olefin monomer, having a cyclic hydrocarbon skeleton, and the port member is formed from a resin having a crystalline polyolefin having no cyclic hydrocarbon skeleton, as a main component.

A plastic container has superior storage stability for pharmaceutical ingredients exhibiting a high affinity to plastic and can be mass-produced at low cost. The container has a bag body formed into a bag shape by a sheet member with a storage part on the inside thereof, and a tubular port member attached to the bag body, wherein one end of the tubular port member communicates with the storage part and an opening part of the other end is exposed outside of the bag body. The sheet member is formed from two or more layers including a base resin layer and an innermost layer formed from an amorphous polymer, as a main component, formed by polymerizing at least one type of olefin monomer, having a cyclic hydrocarbon skeleton, and the port member is formed from a resin having a crystalline polyolefin having no cyclic hydrocarbon skeleton, as a main component.

This method of 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, a first acidic water and a first water-soluble organic solvent, and that exhibits a phenylhydrazine concentration of 0.01 g/mL to 10 g/mL; obtaining a second measured value by measuring the phenylhydrazine content in a sample solution that contains a 3-methyl-1-phenyl-2-pyrazolin-5-one bulk drug, a second acidic water and a second water-soluble organic solvent; and detecting the phenylhydrazine content in the 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 aqueous acetic acid solution, and the like, the first water-soluble organic solvent is at least one type selected from acetonitrile and methanol, the second acidic water is at least one type selected from hydrochloric acid, an aqueous acetic acid solution, and the like, and the second water-soluble organic solvent is at least one type selected from acetonitrile, and methanol.

The present invention relates to novel ACSS2 inhibitors having activity as anti-cancer therapy, treatment of alcoholism, and viral infection (e.g., CMV), composition and methods of preparation thereof, and uses thereof for treating viral infection, alcoholism, alcoholic steatohepatitis (ASH), non-alcoholic steatohepatitis (NASH), obesity/weight gain, anxiety, depression, post-traumatic stress disorder, inflammatory/autoimmune conditions and cancer, including metastatic cancer, advanced cancer, and drug resistant cancer of various types.

The present invention relates to novel ACSS2 inhibitors having activity as anti-cancer therapy, treatment of alcoholism, and viral infection (e.g., CMV), composition and methods of preparation thereof, and uses thereof for treating viral infection, alcoholism, alcoholic steatohepatitis (ASH), non-alcoholic steatohepatitis (NASH), obesity/weight gain, anxiety, depression, post-traumatic stress disorder, inflammatory/autoimmune conditions and cancer, including metastatic cancer, advanced cancer, and drug resistant cancer of various types.

The invention relates to a salt of 3-methyl-1-phenyl-2-pyrazolin-5-one (edaravone), wherein the salt is 3-methyl-1-phenyl-2-pyrazolin-5-one napadisylate or 3-methyl-1-phenyl-2-pyrazolin-5-one hemi-napadisylate. These napadisylate salts of edaravone are easy to manufacture and dissolve more rapidly in water than the free edaravone base. In addition, the edaravone salts of the present invention are very stable and easy to handle.

The invention also relates to a pharmaceutical composition comprising the aforementioned edaravone salt and to a method of preparing such edaravone salt.

To provide a preservative solution for live cells or a composition containing live cells, a method for preserving live cells or a composition containing live cells by use of the preservative solution and the like, the preservative solution being easy to prepare and exhibiting a high cytoprotective effect, especially during low-temperature storage. The preservative solution for live cells or a composition containing live cells contains vitamin C and/or vitamin E or edaravone in a solution serving as a base of the preservative solution, for example, a physiological isotonic solution.

The present invention relates to novel ACSS2 inhibitors having activity as anti-cancer therapy, treatment of alcoholism, and viral infection (e.g., CMV), composition and methods of preparation thereof, and uses thereof for treating viral infection, alcoholism, alcoholic steatohepatitis (ASH), non-alcoholic steatohepatitis (NASH), obesity/weight gain, anxiety, depression, post-traumatic stress disorder, inflammatory/autoimmune conditions and cancer, including metastatic cancer, advanced cancer, and drug resistant cancer of various types.