PROCESS FOR PREPARING A NEW CRYSTALLINE ATORVASTATIN HEMICALCIUM SALT POLYMORPH FORM
The invention relates to a new crystalline polymorph form of atorvastatin hemicalcium salt [calcium salt of (3R, 5R)-7 - [3-phenyl-4- (phenyl carbamoyl) -2- (4 -fluorophenyl) -5- (1-methylethyl) -1H-pyrrol-1-yl] -3, 5-dihydroxy-heptanoic acid (2:1)], to medicinal preparations containing the new poly...
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Sprache: | eng ; rum |
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Zusammenfassung: | The invention relates to a new crystalline polymorph form of atorvastatin hemicalcium salt [calcium salt of (3R, 5R)-7 - [3-phenyl-4- (phenyl carbamoyl) -2- (4 -fluorophenyl) -5- (1-methylethyl) -1H-pyrrol-1-yl] -3, 5-dihydroxy-heptanoic acid (2:1)], to medicinal preparations containing the new polymorph form, to a process for the preparation thereof and the use of the new polymorph form. The claimed polymorph form has an X-ray diffractogram, as presented in Figure 1.
Invenţia se referă la o formă polimorfă, cristalină, a sării hemicalcice a atorvastatinului [sarea de calciu a acidului (3R,5R)-7-[3-fenil-4-(fenilcarbamoil)-2-(4-fluorfenil)-5-(1-metiletil)-1H-pirol-1-il]-3,5-dihidroxiheptanoic (2:1)], la preparatele medicinale care o conţin, la un procedeu de preparare a acesteia şi la utilizarea acestei forme polimorfe. Forma polimorfă conform invenţiei are o difractogramă cu raze X, prezentată în fig. 1. |
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