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US 2012/0111098 A1Published application
2- acetamide
AssigneeMedichem, S.A.
InventorAna Gavaldá Escudé
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Abstract
The invention relates to 2-{2-amino-3-[hydroxy(phenyl)methyl]phenyl}acetamide, a process for its preparation, and its use as a reference marker and reference standard for analyzing the purity of nepafenac.
Claims7
1-6. (canceled)
A method for determining the purity of a nepafenac sample comprising analyzing the sample for the presence of a compound of formula (V):
A method for determining the purity of a nepafenac sample comprising quantifying the amount of a compound of formula (V):
- in the nepafenac sample utilizing a reference standard sample of a compound of formula (V).
A method of quantifying the amount of compound of formula (V):
- said method comprising:
- (i) providing a sample of nepafenac containing an unknown amount of a compound of formula (V);
- (ii) measuring by HPLC the area under the peak corresponding to compound of formula (V) in the nepafenac sample;
- (iii) measuring by HPLC the area under a peak corresponding to nepafenac in a reference standard sample having a known amount of nepafenac and/or having a known amount of compound of formula (V);
- and
- (iv) determining the amount of compound of formula (V) in the nepafenac sample of step (i) by comparing the area calculated in step (ii) with the area calculated in step (iii).
3 more elements
Dependencies are inferred from the claim text.