Composition with a high degree of purity, containing (717th)- 17-hydroxy-7-methyl-19-nor-17-pregn-5(10)-ene-20-in-3-one, its preparation, pharmaceutical standard dosage forms

 

The invention relates to a method of obtaining the composition (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)-ene-20-in-3-one with a high degree of purity. This way we obtain a composition with a content of (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-4-EN-20-in-3-it is less than 0.5%, which can be used as a source for the preparation of stable pharmaceutical standard dosage forms. 5 S. and 9 C.p. f-crystals, 3 tables.

Description text in facsimile form (see graphic part)and

Claims

1. Composition with a high degree of purity, containing (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)EN-20-in-3-one, characterized in that the above composition contains (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-4-EN-20-in-3-one in the amount of less than 0.5%.

2. The composition according to p. 1, characterized in that the number (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-4-EN-20-in-3-it is 0.25% or less.

3. The composition according to p. 1, characterized in that to the place of 0.1% or less.

4. The way to obtain compositions with a high degree of purity on PP.1-3, characterized in that the crystals (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)EN-20-in-3-leave it to Mature in the presence of water for at least 24 hours

5. The method according to p. 4, in which the maturation lasts for 3-6 days.

6. The method according to p. 4 or 5, characterized in that the crystals are formed at the last stage of the synthesis tibolona, comprising the following stages:

A. interaction (717th)-3,3-dimethoxy-17-hydroxy-7-methyl-19-norpregna-5(10)EN-20-in-3-one in an organic solvent with a weakly acidic aqueous solution,

b. pouring the solution into water, which is poorly alkalinized,

C. washing the crystals with water, which is poorly alkalinized.

7. Pharmaceutical standard dosage form, which is obtained by mixing the pharmaceutically acceptable solid carrier and a composition according to any one of paragraphs.1-3.

8. Pharmaceutical standard dosage form, which is obtained by mixing the pharmaceutically acceptable solid carrier and a composition obtained by the method according to any one of paragraphs.4-6.

9. Standard dosage form, clucarotti-7-methyl-19-nor-17-pregn-5(10)EN-20-in-3-one fewer than 2,50 mg and has a certain shelf life, when the content of (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-4-EN-20-in-3-it is less than 5%.

10. Standard dosage form under item 9, characterized in that (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)EN-20-in-3-it is contained in the amount of 1.25 mg or less.

11. Standard dosage form under item 9, characterized in that (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)EN-20-in-3-it is contained in the amount of 0.625 mg or less.

12. Standard dosage form according to any one of paragraphs.9-11, which has a shelf life of 1.5 years, more preferably 2 years.

13. Standard dosage form on PP.9-11, which at the expiration of 6 months number (717th)-17-hydroxy-7-methyl-19-nor-17-pregn-4-EN-20-in-3-she is 3% or less, more preferably 2% or less.

14. Standard dosage form under item 13, in which the shelf life is 1 year, preferably 1.5 years, more preferably 2 years.

 

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