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US 7,741,482 B2Granted
Reference standard for characterization of rosuvastatin
AssigneeTeva Pharmaceutical Industries Ltd.
InventorNina Finkelstein
Life of this patent
Estimating the term…
Abstract
Provided are rosuvastatin degradation products and their use as a reference standard (including reference marker) for analysis of rosuvastatin.
Claims5
A lactone form of a rosuvastatin degradation product having the following structure:
- wherein, in the lactone form, C1 and C5 form an ester derivative of formula:
- wherein R4 is a hydrogen and R represents the rest of the structure of the rosuvastatin degradation product.
A mixture comprising:
- (i) a lactone form of rosuvastatin degradation product I
- wherein, in the lactone form, C1 and C5 form an ester derivative of formula:
- wherein R4 is a hydrogen and R represents the rest of the structure of the rosuvastatin degradation product;
- and
- (ii) a lactone form of rosuvastatin degradation product II
- wherein, in the lactone form, C1 and C5 form an ester derivative of formula:
- wherein R4 is a hydrogen and R represents the rest of the structure of the rosuvastatin degradation product;
- and wherein the lactone form of rosuvastatin product II is less than 5% by HPLC in relation to product I in the mixture.
5 more elements
Dependencies are inferred from the claim text.