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Clorazepate Dipotassium, USP

Clorazepate Dipotassium, USP

7-Cloro-2,3-dihydro-2-oxo-5-phenyl-1H-1, 4-benzodiazepine-3-carboxylic acid
Dipotassium Salt

 
C16H11Cl K2N2O4
Mol. Wt.: 408.93
CAS 57109-90-7
 
Description
Off-white to light yellow crystalline powder.
 
Solubility
Soluble in water, slightly soluble in ethanol and 2-propanol, almost insoluble in chloroform, ether, acetone and methylene chloride.
 
Identification

  1. IR Spectrum: conforms to that of USP standard.
  2. Ultraviolet absorption: The ultraviolet spectrum conforms to that of USP standard.
 
Loss on Drying
Not more than 0.5%.
 
Heavy Metals
Not more than 20 ppm.
 
Assay
98.5% - 101.5% (calculated on dried basis)
 
Storage
Keep in a well-closed container. Protect from light.
 
Medical Use
As tranquilizer, anxiolytic.
 
Related Compounds
  1. TLC
    • No secondary spot is larger or more intense than the principal spot obtained from standard preparation (NMT 0.5%).
    • Any violet-coloured spot is not greater in size or intensity than the principal spot obtained from standard solution B (0.1%).
    • Total impurity spot: NMT 1%.
  2. HPLC
    • 7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepine-2-one impurity is less than 0.4%.
    • 2-Amino-5-chlobenzophenone impurity is less than 0.1%.
Method of analysis is available on request.

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