lopinavir and its Impurities
Lopinavir is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir. It is an antiretroviral of the protease inhibitor class. Reference standards of Lopinavir API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


Lopinavir - Impurity T
2-(2,6-Dimethylphenoxy)-N-[(2S,3S,5S)-5-([[(2S,4S,5S)-5-[[(2,6-dimethylphenoxy)acetyl]amino]-4-hydroxy-1,6-diphenylhexan-2-yl]carbamoyl]amino)-3-hydroxy-1,6-diphenylhexan-2-yl]acetamide
Catalogue No.:PA 12 32200
CAS :
1797024-56-6
Molecular Formula : C57H66N4O7
Molecular Weight : 919.18


3-Methyl-2-(2-oxo-tetrahydro-pyrimidin-1-yl)-pentanoic Acid{1-benzyl-4-[2-(2-6,-dimethyl-phenoxy)-acetylamino]-3-hydroxy-5-phenyl-pentyl}-amide
3-Methyl-2-(2-oxo-tetrahydro-pyrimidin-1-yl)-pentanoic Acid{1-benzyl-4-[2-(2-6,-dimethyl-phenoxy)-acetylamino]-3-hydroxy-5-phenyl-pentyl}-amide
Catalogue No.:PA 12 32520
CAS :
NA
Molecular Formula : C38H50N4O5
Molecular Weight : 642.84


(S)-N-((2S,4S,5S)-4-(((6-(Cyclopropylamino)-9-((1S,4S)-4-(hydroxymethyl)cyclopent-2-en-1-yl)-9H-purin-2-yl)amino)methoxy)-5-(2-(2,6-dimethylphenoxy)acetamido)-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
(S)-N-((2S,4S,5S)-4-(((6-(Cyclopropylamino)-9-((1S,4S)-4-(hydroxymethyl)cyclopent-2-en-1-yl)-9H-purin-2-yl)amino)methoxy)-5-(2-(2,6-dimethylphenoxy)acetamido)-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
Catalogue No.:PA 12 32530
CAS :
NA
Molecular Formula : C52H66N10O6
Molecular Weight : 927.16


(2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino-3-hydroxy-5-trifluromethylcarbonylamino-1,6-diphenylhexane
(2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino-3-hydroxy-5-trifluromethylcarbonylamino-1,6-diphenylhexane
Catalogue No.:PA 12 32540
CAS :
NA
Molecular Formula : C30H33F3N2O4
Molecular Weight : 542.6


(S)-N-((2S,4S,5S)-5-(2-(2,6-Dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-2-(2,4-dioxotetrahydropyrimidin-1(2H)-yl)-3-methylbutanamide
(S)-N-((2S,4S,5S)-5-(2-(2,6-Dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-2-(2,4-dioxotetrahydropyrimidin-1(2H)-yl)-3-methylbutanamide
Catalogue No.:PA 12 0321000
CAS :
192725-39-6
Molecular Formula : C37H46N4O6
Molecular Weight : 642.8


Lopinavir - Impurity R
(2S)-N-[(1S,3S,4S)-1-Benzyl-4-[[2-(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenylpentyl]-2-[3-[2-(2,6-dimethylphenoxy)acetyl]-2-oxotetrahydropyrimidin-1(2H)-yl]-3-methylbutanamide,
Catalogue No.:PA 12 0320180
CAS :
943250-66-6
Molecular Formula : C47H58N4O7
Molecular Weight : 791


Lopinavir - Impurity D
(1R,3R)-1-[(1R)-1-[[2-(2,6-Dimethylphenoxy)acetyl]amino]-2-phenylethyl]-3-[[(2R)-3-methyl-2-[2-oxotetrahydropyrimidin-1(2H)-yl]butanoyl]amino]-4-phenylbutyl hydrogen sulfate
Catalogue No.:PA 12 0320040
CAS :
NA
Molecular Formula : C37H48N4O8S
Molecular Weight : 708.87


Lopinavir - Impurity C
(2R)-N-[(1S,2S,4S)-1-Benzyl-2-hydroxy-4-[[(2S)-3-methyl-2-[2-oxotetrahydropyrimidin-1(2H)-yl]butanoyl]amino]-5-phenylpentyl]-3-methyl-2-[2-oxotetrahydropyrimidin-1(2H)-yl]butanamide
Catalogue No.:PA 12 0320030
CAS :
NA
Molecular Formula : C36H52N6O5
Molecular Weight : 648.85


N-(5-(2-(2,6-dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)pentanamide
N-(5-(2-(2,6-dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)pentanamide
Catalogue No.:PA 12 0321004
CAS :
943238-69-5
Molecular Formula : C38H50N4O5
Molecular Weight : 642.84


Lopinavir - Impurity O
(2S,3S,5S)-2-[[(2,6-Dimethylphenoxy)acetyl]amino]- 5-[[(2S)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)- yl)butanoyl]amino]-1,6-diphenylhexan-3-yl (2S)-3-methyl-2-(2- oxotetrahydropyrimidin-1(2H)-yl)butanoate
Catalogue No.:PA 12 0320150
CAS :
NA
Molecular Formula : C46H62N6O7
Molecular Weight : 811.04


(2S,3S,5S)-2-(N,N-Dibenzylamino)-3-hydroxy-5-(tert-butyloxycarbonylamino)-1,6-diphenylhexane
(2S,3S,5S)-2-(N,N-Dibenzylamino)-3-hydroxy-5-(tert-butyloxycarbonylamino)-1,6-diphenylhexane
Catalogue No.:PA 12 0321005
CAS :
162849-93-6
Molecular Formula : C37H44N2O3
Molecular Weight : 564.77


(S)-N-((2S,4S,5S)-4-Hydroxy-5-(2-(4-(2-(((2S,3S,5S)-3-hydroxy-5-((S)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamido)-1,6-diphenylhexan-2-yl)amino)-2-oxoethoxy)-3,5-dimethylphenyl)acetamido)-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
(S)-N-((2S,4S,5S)-4-Hydroxy-5-(2-(4-(2-(((2S,3S,5S)-3-hydroxy-5-((S)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamido)-1,6-diphenylhexan-2-yl)amino)-2-oxoethoxy)-3,5-dimethylphenyl)acetamido)-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
Catalogue No.:PA 12 0321009
CAS :
1989516-33-7
Molecular Formula : C66H86N8O9
Molecular Weight : 1135.46


(S)-N-((2S,4S,5S)-5-(2-(2,6-Dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-4-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)pentanamide
(S)-N-((2S,4S,5S)-5-(2-(2,6-Dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-4-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)pentanamide
Catalogue No.:PA 12 0321010
CAS :
1132765-60-6
Molecular Formula : C38H50N4O5
Molecular Weight : 642.84


tert-Butyl ((2S,4S,5S)-5-(2-(2,6-dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)carbamate
tert-Butyl ((2S,4S,5S)-5-(2-(2,6-dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)carbamate
Catalogue No.:PA 12 0321011
CAS :
192725-45-4
Molecular Formula : C33H42N2O5
Molecular Weight : 546.71