Evaluation of the consistency of isosorbide nitrate tablets
- time:2020-03-03
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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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