Bimatoprost crystalline form i

Abstract

The invention provides a novel polymorphic form I of crystalline bimatoprost, method for preparation thereof and new crystalline intermediates in the preparation. This form I of crystalline bimatoprost is used in purification of crude bimatoprost and in storage of bimatoprost as active pharmaceutical intermediate. Use of the physical form of bimatoprost in the manufacture of a medicament is also disclosed.

1 . A pure bimatoprost, wherein said bimatoprost contains (by HPLC) not more than (NMT) 2% of sum of all related impurities and 1% of 5-trans isomer. 
     
     
         2 . The pure bimatoprost according to  claim 1 , wherein said bimatoprost contains (by HPLC) not more than (NMT) 1.5% of sum of all related impurities and 0.7% of 5-trans isomer. 
     
     
         3 . The pure bimatoprost according to  claim 1 , wherein said bimatoprost contains (by HPLC) not more than (NMT) 1% of sum of all related impurities and 0.5% of 5-trans isomer. 
     
     
         4 . The pure bimatoprost according to  claim 1 , wherein said bimatoprost is free of 5-trans and 15(R)-isomers of bimatoprost. 
     
     
         5 . The pure bimatoprost according to  claim 1 , wherein said bimatoprost contains by LC not more than (NMT) 0.2% each of 5-trans isomer and 15(R) isomer. 
     
     
         6 . The pure bimatoprost according to  claim 1 , wherein said bimatoprost contains by LC not more than (NMT) 0.1% each of 5-trans isomer and 15(R) isomer. 
     
     
         7 . The pure bimatoprost according to  claim 1 , wherein said bimatoprost contains by LC not more than (NMT) 0.05% each of 5-trans isomer and 15(R) isomer. 
     
     
         8 . A method for preparing a pharmaceutical or cosmetic composition by combining effective amount of said bimatoprost according to  claim 1  with a pharmaceutical or cosmetic acceptable vehicle. 
     
     
         9 . Use of crystalline form I of bimatoprost for the preparation of pure bimatoprost.