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Evaluation of the consistency of isosorbide nitrate tablets

  • time:2020-03-03
  • browse:1039second

一、 Basic information 

Chinese name: Isosorbide nitrate tablets 

English name: Isosorbide Dinitrate Tablets 

Pinyin: Xiaosuanyishanlizhi Pian

 Dosage form: Tablet 

specifications: 5mg, 10mg (domestic tablet specifications) 

Chemical name: 1,4: 3,6-II Anhydrous-D-sorbitol dinitrate 

Molecular formula: C6H8N2O8 

Molecular weight: 236.14 

CAS number: 87-33-2 

Physical and chemical properties: This product is a white crystalline powder; it is odorless; it is easy to explode when heated or hit. 

Solubility of drug substance: This product is soluble in acetone or chloroform, slightly soluble in ethanol, slightly soluble in water. 

二、Drug indications:

 Long-term treatment of coronary heart disease; prevention of angina pectoris; treatment of persistent angina pectoris after myocardial infarction; combined use with digitalis and / or diuretics to treat chronic congestive heart failure; treatment of pulmonary hypertension. 

三、Reference preparations: 

PAP PHARM's isosorbide nitrate tablets have 4 specifications, 5mg, 10mg, 20mg, and 30mg, and 30mg contained in the FDA are reference preparations VALEANT PHARMS NORTH

The company's isosorbide nitrate tablets have 5 specifications, 5mg, 10mg, 20mg, 30mg, and 40mg, and the 40mg contained by the FDA is the reference preparation. 10mg, 20mg and 30mg discontinued production and delisting. AUXILIUM PHARMS INC 40mg is the reference preparation.


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