Impurity Standard List

Amlodipine Besilate

Structure Chemical name EP USP Glochem(in-house/process) Remarks
3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl) ethoxy] methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity-A
     
3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2-(methylcarbamoyl)benzoyl] amino]-ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate
Impurity-B
     
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate
Impurity-D
Impurity-A
   
Diethyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity-E
     
Dimethyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate,
Impurity-F
     
Dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate.
Impurity-G
     
2-[[2-[[(4RS)-4-(2-chlorophenyl)-3-(ethoxycarbonyl)-5-methoxycarbonyl)-6-methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl] carbamoyl]benzoic acid
Impurity-H
   
Not feasible in our process
2[(2-aminoethoxy) methyl]-3 ethoxy carbonyl-5-methoxy carbonyl 4-phenyl-6-methyl-1,4 dihydropyridine besilate.    
Deschloro Analogue of Amlodipine
 

Amlodipine Maleate – In-house

Structure Chemical name
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate.
2,6-dimethyl-4(2-chlorophenyl)-3-ethoxy carbonyl-5-methoxy carbonyl-1,4-dihydropyridine

Amlodipine Mesylate – In-house

Structure
Chemical name
Glochem(in-house/process)
3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl) ethoxy] methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity-A
3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2-(methylcarbamoyl)benzoyl] amino]-ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate,
Impurity-B
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate.
Impurity-D
Diethyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity-E
Dimethyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate,
Impurity-F
Dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate.
Impurity-G
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-phenyl)-6-methylpyridine-3,5-dicarboxylate.
Deschloro

Cetirizine Dihydrochloride

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
(RS)-1-[(4-chlorophenyl) phenylmethyl] piperazine
Impurity A
     
(RS)-2-[4-[(4-chlorophenyl) phenylmethyl] piperazin-1-yl] acetic acid,
Impurity B
     
(RS)-2-[2-[4-[(2-chlorophenyl) phenylmethyl] piperazin-1-yl]ethoxy]acetic acid
Impurity C
     
1,4-bis [(4chlorophenyl) phenyl methyl] piperazine,
Impurity D
     
(RS)-2-[2-[2-[4-(4-Chlorophenyl) Phenyl methyl] Piperazine-1-yl] ethoxy]ethoxy] acetic acid (ethoxy cetirizine)
Impurity E
   
Not feasible in our process
(RS)-2-[2-[4-(diphenylmethyl) piperazin-1-yl] ethoxy] acetic acid
Impurity F
     
2-[4-[(RS)-(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethanol
Impurity G
     

Eprosartan Mesylate –In-House

Structure
Chemical name
Glochem(inhouse/process)
Remarks
Thiophene-2-propanoic acid
Impurity-B
 

Levo cetirizine dihydrochloride

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
(RS)-1-[(4 chlorophenyl) phenylmethyl] piperazine
   
Impurity A
 
(RS)-2-[4-[(4-chlorophenyl) phenylmethyl] piperazin-1-yl] acetic acid
   
Impurity B
 
(RS)-2-[2-[4-[(2 chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] acetic acid
   
Impurity C
 
1,4-bis[(4-chlorophenyl)phenylmethyl]piperazin
   
Impurity-D
 
[2-[4-(diphenylmethyl)piperzin-1-yl)ethoxy]acetic acid
   
Impurity-F
 
2-[4-[(RS)-4-chlorophenyl)phenylmethyl]piperzin-1-yl]ethanol
   
Impurity-G
 
(R) 2-[2-[4-[(4 – chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydrochloride.
   
S(-) Enantiomer Enantiomeric form
 

Telmisartan

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
4-methyl-6-(1-methyl-1H-benimidazol-2-yl)-2-propyl-1H-benzimidazole
Impurity A
Related compound-A
   
4′-[[7-methyl-5-(1-methyl-1H-benimidazol-2-yl)-2-propyl-1H-benzimidazol-1- yl]methyl]biphenyl-2-carboxylic acid
Impurity B
Related compound - C
   
1,1-dimethylethyl 4′-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl]biphenyl-2-carboxylate
Impurity C
Telmisartan tertiary butyl ester(related compound – E)
   
--
unidentified impurity-
Impurity D
     
1-[(2′-caroxybiphenyl-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazol-6-carboxylic acid
Impurity E
Telmisartan diacid(related compound-D)
   
4′-[[4-methyl-6-(1-methyl-1H-benimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl] methyl] biphenyl-2-carboxamide
Impurity F
Telmisartan Amide(Related compound-B)
   
4′-[[4-methyl-6-(1-methyl-1H-benimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl] methyl] biphenyl-2-carbonitrile
Impurity G
     
1,1-dimethylethyl 4′-(bromomethyl)biphenyl-2-carboxylate
Impurity H
     

Tolcapone

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
4- N- Methyl 3,4dihydroxyl benzophenone
 
Related compound-A
   
4- Hydroxy-3- methoxy -4' methyl 5- nitro benzophenone.
 
Related compound-B
   

Dronedarone Hydrochloride

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
N-(2-butyl-3-(4-(3-(dibutylamino) propoxy) benzoyl) benzofuran-5-yl) formamide.
   
Formamide impurity
 
N-(2-butyl-3-(4-(3-(dibutylamino) propoxy) benzoyl) benzofuran-5-yl)-N- (Methylsulfonyl) methane sulfonamide.
   
Disulfonamide(Bis) impurity
 
N-(2-butyl-3-(4-methoxy benzoyl)benzofuran-5-yl)methane sulfonamide.
   
Methooxy sulfonamide impurity
 
N-(2-butyl-3-(4-hydroxy benzoyl) benzofuran-5-yl)methane sulfonamide.
   
Des dibutyl amino propane of dronedarone impurity
 

OLMESARTAN MEDOXOMIL

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
4-(1-hydroxy-1-methyl)-2-propyl-1-[[2’-1H-tetrazol-5-yl]biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylicacid
Impurity-A
     
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl-4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2’-[(2-triphenylmethyl)-2H-tetrazol-5-yl]biphenyl-4-yl]methyl]-1H-imidazol-5-carboxylate
Impurity-D
     

CINACALCET HYDROCHLORIDE

Structure
Chemical name
EP
USP
Glochem(in-house/process)
Remarks
3-(3-methyl phenyl)propanoic acaid
   
Process
 
3-(3-methyl phenyl)-N-[(1S)-1-(naphthyen-1-yl)ethyl)propanamide
   
Process
 
3-(3-methyl phenyl)-N-[(R)-1-(naphthyen-1-yl)ethyl)propanamide
   
Process
 
3-(3-methyl phenyl)-N-[(1S)-1-(naphthalene-1-yl)ethyl]propan-1-amine
   
Process
 
3-(3-methyl phenyl)-N-[(1R)-1-(naphthalene-1-yl)ethyl]propan-1-amine
   
Process
 
(2E)-N-[(1S)-1-(naphthalene-1-yl)]-3-(3-trifluoro methyl)phenyl)prop-2-enamide
   
Process
 
(2E)-N-[(1R)-1-(naphthalene-1-yl)]-3-(3-trifluoro methyl)phenyl)prop-2-enamide
   
Process
 
N-[(1S)-1-(naphthalen-1-yl)ethyl)-3-[3-trifluoromethyl0phenyl]propanamide
   
Process
 
N-[(1S)-1-(naphthalen-1-yl)ethyl)-3-[3-trifluoromethyl0phenyl]propan-1-amine
   
Process