EOS Med Chem, Medicinal Chemical is Big

2018年3月5日星期一

Impurity List

EOS Med Chem, Medchem is Big

執大象，天下往，往而無害，安平泰

網址: www.eosmedchem.com

2018. 4.18 Japan CPHI, Attend

2018. 5.15 Israel Biomed, Attend

2018. 6. 20 China CPHI, W4E82

2018. 8. 28 Korea CPHI, Attend

2018. 10. 9 Spain World CPHI, Attend

郵箱: info@eosmedchem.com; eosmedchem@gmail.com

住所: Diaozhen Chemical Industrial Park, Jinan City, China

Alfuzosin EP Impurity B

2-chloro-6,7-dimethoxyquina zolin-4-amine / 4-Amino-2- chloro- 6,7-dimethoxy quinazoline

Alfuzosin EP Impurity F

N-(3-(((4-amino-6, 7-dihydro xyquinazolin-2-yl) methyl) (methyl) amino) propyl) tetrahydrofuran-2- carboxamide

Colsevelam Impurities

Aziobis (Colsevelam impurity- 7)

2,2’-azobis(2- amidinopropane) dihydrochloride

Lidocaine Impurities

Lidocaine BP Impurity B / Lidocaine N-Oxide

2-(Diethylazinoyl)-N-(2,6- dimethylphenyl)acetamide

Lidocaine BP Impurity H

2-Chloro-N-(2,6- dimethylphenyl) acetamide

Lidocaine BP Impurity C

N-(2,6-Dimethylphenyl) acetamide

Lidocaine BP Impurity D

N-(2,6-Dimethylphenyl)-2- (ethylamino) acetamide HCl

Lidocaine BP Impurity F / Lidocaine 2,3-Dimethyl Analog

2-(Diethylamino)-N-(2,3- dimethyl phenyl) acetamide

Lidocaine BP Impurity G

N-(2,6-Dimethylphenyl)-2-[(1- methylethyl)amino]acetamide HC

Lidocaine BP Impurity I / Lidocaine 2,4-Dimethyl Analog

2-(Diethylamino)-N-(2,4- dimethylphenyl)acetamide

Lidocaine BP Impurity K / N- Desethyl-N-Methyl Lidocaine HCl

N-(2,6-Dimethylphenyl)-2- (ethylmethylamino)acetamid

Quetiapine Impurities

Quetiapine EP Impurity D / Quetiapine Dimer

11,11’-(1,4-Piperazinediyl)bis- dibenzo[b,f][1,4]thiazepine;

Quetiapine EP Impurity B / Quetiapine Related Compound B

11-(Piperazin-1-yl)dibenzo[b,f] [1,4]thiazepine dihydrochloride

Quetiapine EP Impurity P

11-(4-Ethyl-1-piperazinyl)- dibenzo [b,f][1,4]thiazepine Dihydrochloride

Quetiapine EP Impurity T

11-Morpholino- dibenzo[b,f][1,4] thiazepine hydrochloride

Quetiapine EP Impurity G

dibenzo [b, f] [1, 4] thiazepin- 11(10H)-one

Quetiapine Desethoxy Impurity / Quetiapine EP Impurity I

2-(4-

(dibenzo[b,f][1,4]thiazepin- 11-yl)piperazin-1-yl)ethanol hemifumarate

Cetirizine Impurities

VL330010

Cetirizine 4-chlorobenzhydrol Impurity / Meclizine USP Related Compound A

Cetirizine 4-chlorobenzhyrole

VL330011

Cetirizine 4- chlorobenzophenone Impurity

(4-Chlorophenyl) phenylmethanone

Cinacalcet Impurities

VL2310013

Cinacalcet Phenyl Isomer Impurity

(R)-N-(1-(naphthalen-1- yl)ethyl)-3-phenylpropan-1- amine

VL2310023

Cinacalcet 6-Ethanamine Impurity

1-(Naphthalen-6- yl)Ethanamine

VL2310027

Cinacalcet 6-Ethanone Impurity

1-(Naphthalen-6-yl)Ethanone

VL2310020

Cinacalcet 6-Ethanol Impurity

1-(Naphthalen-6-yl)Ethanol

VL2310037

Cinacalcet Impurity I

(E)-3-(3-

(trifluoromethyl)phenyl) acrylic acid

VL2310013

Cinacalcet Phenyl Isomer Impurity

(R)-N-(1-(naphthalen-1- yl)ethyl)-3-phenylpropan-1- amine

Venlafaxine Impurities

VL286005

Venlafaxine EP Impurity C

1-[2-Amino-1-(4-

methoxyphenyl) ethyl]cyclohexanol Hydrochloride

Darifenacin Impurities

VL1530004

Darifenacin Bromo impurity

5-(2-Bromoethyl)-2,3- dihydrobenzo [2,3-b]furan

VL1530005

Darifenacin Cyano Pyrrolidine Impurity

(S)-3-(Cyanodiphenylmethyl)- pyrro lidine HBr/(3S)-α,α- Diphenyl-3- pyrrolidineacetonitrile Hydrochloride

Trazodone Impurities

VL620006

Trazodone Impurity F / Trazodone Related Compound F

1-(3-chlorophenyl)-4-(3-chloro propyl)piperazine hydrochloride

VL620015

3-chlorophenyl piperazine HCl salt

1-(3-Chlorophenyl)piperazine Hydrochloride

Nicotinamide Impurities

VL2180005

Nicotinamide Impurity A / Nicotinic Acid

3-Pyridinecarboxylic Acid/3- Carboxylpyridine/Niacin

VL2180001

Nicotinamide Impurity B / 3- pyridin ecarbonitrile / Nicotinonitrile

3-Azabenzonitrile/3- Cyanopyridine

VL2180002

Nicotinamide Impurity C / Picolinamide

2-Pyridinecarboxamide/2- Carbamoylpyridine

VL2180003

Nicotinamide Impurity D / Isonicotinamide

4-Pyridinecarboxamide/4- (Aminocarbonyl)pyridine

VL2180004

Nicotinamide Impurity E / Nicotinamide N-Oxide

1-Oxide 3- Pyridinecarboxamide

Albendazole Impurities

VL960001

Albendazole EP Impurity A / Albendazole Amine

5-(Propylsulphanyl) -1H- benzimidazol-2-amine; Desmethoxycarbonyl Albendazole

VL960002

Albendazole EP Impurity B / Sulfoxide

Methyl[5-Propylsulphonyl)- 1H-benzimidazol-2- yl]carbamate; Albendazole Oxide

VL960003

Albendazole Impurity C / Albendazole Sulfone

Methyl[5-Propylsulphonyl)- 1H-benzimidazol-2- yl]carbamate

VL960004

Albendazole EP Impurity D

5-(Propylsulphonyl)- 1Hbenzimidazol-2-amine

Ondansetron Impurities

VL1580001

Ondansetron EP Impurity D

9-Methyl-3-methylene- 1,2,3,9-tetrahydro-4H- carbazol-4-one

VL1580004

Ondansetron EP Impurity H

(3RS)-3-[(2-Methyl-1H-

imidazol-1-yl)methyl]-1,2,3,9- tetrahydro-4H-carbazol-4-one

Bupropion Impurities

VL25004

Chloropropionophenone

3-chloropropiophenone OR 1-

(3-

Chlorophenyl)propan-1-one

VL25014

Bupropion Related Compound C

1-(3-Chlorophenyl)-2-hydroxy- 1-propanone

Olanzapine Impurities

VL109003

Olanzapine Impurity C

1(Chloromethyl) 1methyl4 (2methyl 10Hthieno[2,b][1,5] benzodiazepin-4-yl)- piperazinium Chloride

VL109001

Olanzapine Impurity A / Olanzapine Related Compound A

5-Methyl-2-((2-nitro phenyl)amino)-3- thiophenecarbonitrile

VL109005

Olanzapine Related Compound 07

2-Amino-5-methyl-thiophene- 3-carbonitrile

Clonidine Impurities

VL281001

Clonidine 2,6-dichloroaniline Impurity

2,6-dichloroaniline

VL281004

2,6 dichlorophenyl carbonimidic dichloride / Clonidine Impurity II

2,6 dichloro phenyl carbonimidic dichloride

VL281002

N-(2,6-dichlorophenyl) formamide

Diclofenac Impurities

VL48018

Diclofenac Oxindole Impurity

/ Diclofenac EP Impurity E

1,3-Dihydro-2H-indol-2-one

VL48005

Diclofenac Impurity F

N-Chloroacetyl-(2,6- dichlorophenyl) phenylamine OR (Alpha-(2,6-

Dichlorophenyl)-4- chloroacetanilide)

Omeprazole Impurities

VL112002

Omeprazole Related Compound B / Omeprazole Impurity A

5-methoxy-1H-benzimidazole- 2-thiol

VL112010

Omeprazole Impurity XI

2-Chloromethyl-3,5dimethyl- 4-methoxypyridine Hydrochloride

Fingolimod Impurities

VL1270005

Fingolimod Palmitate Amide

N-(1-Hydroxy-2- (hydroxymethyl)-4-(4- octylphenyl)butan-2- yl)palmitamide

VL1270013

Fingolimod Impurity 7

2-Nitro-2-[2-(4-

octylphenyl)ethyl]-1,3- propanediol

VL1270014

Fingolimod Impurity 12

β-Amino-4- octylbenzenebutanol Hydrochloride

Propafenone Impurities

VL260003

Propafenone EP Impurity C

2'-(Oxiranylmethoxy) -3- phenylpropiophenon

VL260005

Propafenone EP Impurity E

DepropylaMino Chloro Propafenone; 1-[2-(3-Chloro- 2-hydroxypropoxy)phenyl]-3- phenyl-1-propanone

Propranolol Impurities

VL188002

Propranolol Diol Derivative

(2RS)-3-(naphthalen-1- yloxy)propane-1,2-diol

VL188001

Propranolol Epoxide Impurity

2-((naphthalen-1- yloxy)methyl)oxirane

Chlorpromazine Impurities

VL2300003

Chlorpromazine EP Impurity E

Perphenazine 2- Chlorophenothiazine Impurity

Nadolol Impurities

VL1380006

Nadolol EP Impurity F

(2RS)-1-[(1,1-Dimethylethyl) amino] -3-(naphthalen-1- yloxy)propan-2-ol

Rufinamide Impurities

VL3000001

Rufinamide Impurity 6 / USP Rufinamide Related Compound A

1-[(2-Fluorophenyl)methyl]- 1H-1,2,3-triazole-4- carboxamide

VL3000002

Rufinamide Related Compound B

Methyl 1-(2,6-Difluorobenzyl)- 1H-1,2,3-triazole-4- carboxylate

VL3000003

Rufinamide Impurity 1 / 2,6- Didesfluoro Rufinamide

1-(Phenylmethyl)-1H-1,2,3- triazole-4-carboxamide

Fenofibrate Impurities

VL59001 Fenofibrate EP Impurity A (4-chlorophenyl)(4-hydroxy phenyl)methanone

VL59002 Fenofibrate EP Impurity B 2-[4-(4-chlorobenzoyl)phenoxy]-2- methylpropanoic acid

VL59003 Fenofibrate EP Impurity C (3RS)-3-[4-(4-chlorobenzoyl) phenoxy]butan-2-one

VL59004 Fenofibrate EP Impurity D Methyl 2-[4-(4-chlorobenzoyl) phenoxy]- 2-methylpropanoate

VL59005 Fenofibrate EP Impurity E Ethyl 2-[4-(4-chlorobenzoyl) phenoxy]-2- methylpropanoate

VL59006 Fenofibrate EP Impurity F (4-Chlorophenyl)[4-(1- methylethoxy)phenyl]methanone

VL59007

Fenofibrate EP Impurity G 1-methylethyl2-[[2-[4-(4-chloro benzoyl)phenoxy ]-2-methyl propanoyl]oxy]-2-methyl propanoate

Lamotrigine Impurities

VL980007 Lamotrigine Impurity B / E-Isomer of Iminoguanidine For Lamotrigine 2-Cyano-2-[(3,4-dichlorophenyl) hydrazono]acetamide

VL980010 Lamotrigine EP Impurity E 2,3-Dichlorobenzoic acid

VL980008 Lamotrigine EP Impurity D / Dioxo Lamotrigine 6-(2,3-Dichlorophenyl)-1,2,4-triazine- 3,5(2H,4H)-dione; Dioxo Lamotrigine

VL980010 Lamotrigine EP Impurity E 2,3-Dichlorobenzoic acid

VL980011 2,3-Dichlorobenzoyl Cyanide Lamotrigine 2,3-Dichlorobenzoyl Nitrile

VL980012 Lamotrigine Impurity / N2- Methyllamotrigine 6-(2,3-dichlorophenyl)-3-imino-2- methyl-1,2,4-triazin-5-amine

VL980013

Lamotrigine Impurity N,N’-[6-(2,3-Dichlorophenyl)-1,2,4- triazine-3,5-diyl]bis[2,3- Dichlorobenzamide

VL980015 Lamotrigine Impurity / 3,5- Dichlorobenzoyl Cyanide 3,5-Dichlorophenyl(oxo)acetonitrile

VL980016 Lamotrigine Impurity 6-(3,5-Dichlorophenyl)-1,2,4-triazine-3,5- diamine

VL980017 Lamotrigine Impurity 6-(3,4-Dichlorophenyl)-1,2,4-triazine-3,5- diamine

Metoprolol Impurities

VL103004 Metoprolol Related Compound B (+/-)1-chloro-2-hydroxy-3-[4-(2- methoxyethyl)phenoxy]-propane

VL103015 Metoprolol Epoxide Impurity 1-[2-(2-Methoxyethyl)phenyoxy]-2,3- epoxypropane

Aceclofenac Impurities

VL284007 Aceclofenac Impurity A / Diclofenac Sodium 2-(2-(2,6-dichlorophenylamino) phenyl) sodium acetate

VL284005 Aceclofenac Impurity B / Diclofenac Methyl Ester Methyl [2-[(2,6-dichlorophenyl) amino]phenyl]acetate

VL284006 Aceclofenac Impurity C Ethyl [2-[(2,6-dichlorophenyl)amino] phenyl]acetate

VL284002 Aceclofenac Impurity D Dichlorophenyl)amino]benzeneacetic Acid 2-Methoxy-2-oxoethyl Ester

VL284003

Aceclofenac Impurity E 2-[(2,6-Dichlorophenyl)amino] benzene aceticAcid 2-Ethoxy-2-oxoethyl Ester

VL284001

Aceclofenac Impurity F 2-[(2,6-Dichlorophenyl) amino] benzene acetic Acid 2-Oxo-2-(phenyl methoxy) ethyl Ester

VL284004 Aceclofenac Impurity I 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H- indol-2-one

Paracetamol Impurities

VL2170006 Paracetamol Impurity A N-(2-hydroxyphenyl)acetamide

VL2170005 Paracetamol Impurity B N-(4-hydroxyphenyl)propanamide

VL2170007 Paracetamol EP Impurity D Acetylaniline; N-Phenylacetamide; N- phenylcetamide ; Acetanilide

VL2170008 Paracetamol EP Impurity E 1-(4-hydroxyphenyl)ethan-1-one; 4’- Hydroxyacetophenone

VL2170003 Paracetamol EP Impurity F p-Nitrophenol; 1-Hydroxy-4- nitrobenzene

VL2170004 Paracetamol EP Impurity G 4-[1-(hydroxyamino)ethylidene] cyclohexa-2,5-dien-1- one

VL2170009 Paracetamol EP Impurity H N-[4-(Acetyloxy)phenyl]acetamide

VL2170010 Paracetamol EP Impurity I 1-(2-hydroxyphenyl)ethan-1-one

VL2170002 Paracetamol EP Impurity J N-(4-Chlorophenyl)acetamide

VL2170001 Paracetamol EP Impurity K p-Aminophenol; 1-Amino-4- hydroxybenzene

Acetazolamide Impurities

VL11003 Acetazolamide EP Impurity B N-(1,3,4-thiadiazol-2-yl)acetamide

VL11005 Acetazolamide EP Impurity D 2-Amino-1,3,4 thiadiazole-5-Sulfonamide

VL11007

Acetazolamide EP Impurity F N-[5-[(5-Acetamido-1,3,4-thiadiazol-2- yl)sulfonyl]sulfamoyl-1,3,4-thiadiazol-2- yl]acetamide

Aripiprazole Impurities

VL197010 Aripiprazole Impurity A 7-Hydroxy-3,4-dihydroquinolin-2(1H)- one

VL197007 Aripiprazole USP Related Compound G / Aripiprazole EP Impurity E / Dehydro Aripiprazole

7-[4-[4-(2,3-Dichlorophenyl)-1- piperazinyl]butoxy]-2(1H)-Quinolinone

VL197009

Aripiprazole Impurity D 7-[4-[4-(3-Chlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydro-2(1H)- quinolinone

VL197011 Aripiprazole Diquinoline Butanediol Impurity (USP) 1,4-bis[(3,4-Dihydro-2(1H)-quinolinone- 7-yl)oxy]-butane

Carvedilol Impurities

VL35002 Carvedilol Related Compound D 4-(2,3-Epoxypropoxy)carbazole

VL35003

Carvedilol EP Impurity C (2RS)-1-[Benzyl[2-(2-

methoxyphenoxy)ethyl] amino]-3-(9H- carbazol-4- yloxy)propan-2-ol

Atenolol Impurities

VL500008

Atenolol EP Impurity E 2,2’-[2-Hydroxypropan-1,3-diylbis(oxy- 4,1-phenylene)]diacetamide

VL500012 Atenolol EP Impurity H / Atenolol USP Related Compound B 2-[4-[(2RS)-2-hydroxy-3-[(1-

methylethyl)amino]propoxy]phenyl]acet onitrile

VL500007 Atenolol EP Impurity D 2-[4-[(2RS)-3-chloro-2-

hydroxypropoxy]phenyl]acetamide

List of all Levothyroxine Impurities

STRUCTURE CHEMICAL NAME M.F. / M. WT. LEAD TIME

Levothyroxine EP Impurity A (2S)-2-Amino-3-[4-(4-hydroxy-3- iodophenoxy)-3,5- diiodophenyl]propanoic acid Chemical Formula: C15H12I3NO4

Molecular Weight: 650.97