AVAILABLE IMPURITIES DRUG NAME. AlfuzosinHCl. Amlodipine besilate. Aprepitant. Aripiprazole. Aripiprazole. AtomoxetineHcl. Atorvastatin Calcium

Transkrypt

1 DRUG AME AlfuzosinCl Amlodipine besilate Aprepitant Aripiprazole Aripiprazole Atomoxetinecl Atorvastatin Calcium AVAILABLE IMPURITIES Imp-A,B,C,D,E DIMER Methyl ester ofbenzene sulfonic acid, Ethyl ester of benzene sulfonic acid, Isopropyl ester ofbenzene sulfonic acid, Impurity-A,Phthalamidoamlodapine, Impurity-B/ Partialyopendphathalamidoamlodapine, Impurity-D/ Aromatic amlodipine, Impurity-E/Dimethoxyamlodapine, Impurity-/ Para chloroamlodapine, Impurity-G/Diethoxyamlodapine, Dimethoxy-Succino Amlodipine(Imp-) Trans -1-enantiomer,S,R,S-Isomer,DC, DCPP Cl, DehydroAripiprazole, Dimer, dehydro, Dimer, -xide Imp.-1, -xide Imp.-2 MPP impurity, -Acetyl, S-Isomer Methyl ester, Ethyl ester, eptenoic acid, Lactone imp, Diketo compound, Tertiary butyl ester, Difluoro impurity, xirane impurity, BA,SS isomer, Desfluoro impurity, diasteriomer, Di Amino impurity, Methoxy

2 All EP Impurities (A to ) & I Bicultimide Bortizomib Candesartan Cilexetil Candisatran Capacitabine Cetirizine Dihydrochloride Ciprofloxacin Cl Citalopram Clopidogrel Premix EP-A,B,C,G( E& (Mixture) In ouse Impurities also availabe SS,RR(Diasteriomer), SR,Imp-G, Enantiomer, SS-, SR-ydroxy Desethyl impurity, ACID IMP, Ethyl candesartan EP-A,B,G,, Ethyl Candisatran, Des Ethyl Impurity-A, Impurity-B, Impurity-C, 3-Chloro analog, Impurity-D, 3-Chloro, 2-Chloro, Impurity-E, Impurity-, Ethyl ester mpurity, Methyl ester EDA, Chloroanalog, BIPRDUCT, Desfluoro, Q.Acid, Decarboxylated imp EP-A, USP-C,D,E, Butryl Analog Impurity-A,B,C,D,E,,G, 3 Isomer, 4 Isomer, Alchohol impurity, 4 Acid Related compound-a,b, C (USP)

3 Donepezil Cl Doxazosinmesylate Dulaxitine Dutasteride Enalapril maleate Escitalopram Esomeprazole Ezetimibe amotidine exofenadine CL EP-A,B,C,D,E, ydroxy Indene Impurity, Desketo impurity, Methyl impurity, Dibenzyl impurity, Alkene Impurity Impurity-A,B,C,D,E,,G, All EP Impurities EP-A,B,C,D,E Dihydro impurity, Dihydro, DesmethylDutasteride, ISMER Impurity-B,C,D,,G,I xalate salt, Amide impurity, R-Isomer, Des methyl impurity, carbaxylic acid citalopram, Diol citalopram, ther isomer, Imp-E, Benzofurananalog, DPTTA Salt, Butyryl impurity, Impurity E/4-luoro, Benzene analogue A,B,C,D,E,,G, ther isomer, 3-luro isomer, Desfluoro impurity SRR, BEZYL IMPURITY, RSR Diol Impurity A,B,C,D,J,,I,E,, cyclic impurity Related compound-a, Related compound-b, Keto Ester, Cyclopropyl acid,

4 inasteride inofibrate luoxetine cl GalantamineBr Gatifloxacin Glimepiride Ibuprofin Iribisatran Itracanazole Keterolac Lacidipine Lamotrigene Lansoprazole Levo acid Levocetirizinecl Dehydrated Imp, Decarboxylated Imp, ydroxy Ester Impurity- A,B,C,D, Isomer, orm-2 USP-A,B EP-,D Related compound-b(usp), Imp-A,C,D,E (+) Galantamine 8-Methoxy quinolonic acid, 8-ydroxy of Gatifloxacin, Ethyl Quinolonic ester, 3,4-Dimethyl, piperazine derivative Impurity-D,B,C,D, Recemic mixture, Methyl ester Impurity, Imp-C- Inhouse Impurity-C Inouse Impurities also available -A,B,C,D,E,,G Tromethamine, hydroxy imp, Keto imp, Decarboxylated imp, Bromo Impurity 2-ormyl benzoic acid, Impurity-A,B,Dimer imp, Regio imp, TPP Imp, Vinyl aldehyde impurity, TPP Impurity, Decarboxylated Impurity IMP-A,B,C,E, Sulphide imp, Sulphone imp Racemic mixture, Levo acid isomer Impurity-A,B,C,D,E, 3-Chloroanalog, S-isomer Imp,

5 Levofloxacin emihydrate Losartan Potassium salt Meloxicam MemantineCl Mesalamin Metoprolol succinate Montelukast MoxifloxacinCl aproxen ebivolol EP-A,B,C,D,E, Racemic mixture, Imp-A,B,C, -xide mpurity, Decarboxylated impurity, TER ISMER - Trityl imp, Iso-Trityl imp, Isolosartan IMP-L,M Imp-B,C,E,G,, 1-ydroxy-3, 5-dimethyl Adamantane, 1, 3- dimethyl adamantine, 1-Chloro-3,5 -dimethyl, Adamantane Impurity-B,D,E,,,I,J,L,,M,,QR, Metoprolol Compound A, B, C, D, MetoprololDiol Impurity, Epichlorohydrin imp -A,B,C,D Saturated analog, Sulphoxide impurity, Styrine impurity, itrile impurity, Keto impurity, ther Isomer, Amide impurity EP- EP-A,B,C,D,E,, 8-methoxy quinolonic acid, methyl ester, 8-methoxy quinolonic acid, 8-hydroxy of Moxifloxacin, RR-isomer, -Methyl piperazine imp, 8-hydroxy of Quinalonic acid, luoro Impurity, 6,8-Dimethoxy moxi, 8-Ethoxy Moxi. Impurity-A,B,C,D,E, Epoxide Impurity, Aldehyde Impurity, xime Impurity Related -A,B,

6 orfloxacin floxacin lanzapin meprazole meprazole ndansetron Pantaprozole Pantoprazole SSSR-Peak, RRRS-Peak, A-Spot Imp-B,G,, Impurity- (chloro analogue), Imp-C/Dimer, Imp-E or chloro Q-acid, Ethylester, Desfluoro impurity ormyl impurity, Desmethylimpurity, xide, Acetyl, dimer, Quaternary salt Impurity-A, B,C,D,E,,G,,I Chloroompound, Benzimidazole compound.,meprazole Sulfide, -Alkylated Impurity, Desmethoxy meprazole Impurity, Sulfone Impurity, -xide Impurity Impurity-A,C,D,E,,G, Desmethyl impurity Chloro impurity, Benzimidazole, -alkylated, Sulphide imp, -oxide, -oxide sulphide, Sulphone imp, -Methyl impurity/impuirty-d, -Methyl impurity/impuirty- Pantoprazole Chloro compound, Benzimidazole compound, Pantoprazole Sulfide Impurity, Pantoprazole Sulphone Impurity (Impurity- A), Pantoprazole -xide Impurity, Pantoprazole Impurity-D+ (-Methyl Pantoprazole), Pantoprazole -Alkylated Impurity

7 Paroxetenehcl Q.Acid Quetiapine Rabeprazole Sodium Ramipril Ranitidine Repaglinide Risperidone Rivastigmine Rizatriptan Benzoate Ropinrole Rosiglitazone maleate Setraline Imp-E, (+) MP Impurity, USP impurity-, USP impurity-c Methoxy impurity, Chloro analog, Methyl ester, Des fluoro impurity, Positional isomer, 7-luoro, 6-ethoxy All EP- Impurities Impurity-A,B,C,D,E, -Alkylated, Chloro Compound Impurity-C,D,E,,G,,, RRR Isomer, (R,R)-Isomer, Impurity-A,B,C,D,E,,G,I,J,K, Ran--xide, BDMT IMP-A,C,E (EP ), R-isomer, Imp-A,Binhouse, Deschloro imp, ydroxy. Imp,Imp-A (E-Isomer), B(Z- Isomer),C,E,,,I,J,K,L,M, UnreducedRisperidone, -xide, Quantarnary salt DesmethylRivastigmine, DimethylRivastigmine, UndesiredIsomer, Diparatolyl D-Tartaric acid Impurity-A,J, ydrazone Impurity Amino phenyl acetic acid, -ydroxyropinirole, 3-xo Impurity, Despropyl impurity Maleic acid impurity, Dehydro impurity, IMP-2 EP-A,B,C,E,,G

8 Sparfloxacin Sumatriptan Sumatriptan Tadalafil Tamsulosin ydrochloride Telmisartan Telmisatran Terbinafinecl Tizanidine Topiramate Torsemide Valcyclovir Valsatran Deamino, luoroanalog, Diamino, Decyclopropyl, Benzylanalog, YDRXY IMPURITY EP-A,B,C,E Impurity-A,B,C,D,E,,G, EP-A,B,C Trans imsomer, Piperonal, TransTadalafil, L-Tadalafil, -Acetyl-D-Triptophan, D-Triptophan,Methylester, D-Triptophan,methyl ester 2-EPEM, Imp-A,B,C,D,E,,G, Desmethyl, DimerImp, ChloroImpurity, Impurity-B, itrileimpurity, Amideimpurity, Diacid impurity, 4-methyl biphenyl-2-carboxilic acid, 4-methyl biphenyl-2-nitrile EP-A,B,C,D,E, Impurity-1,Impurity-6/Dimer imp, Impurity-3/Z-isomer, Impurity-4/4-MethylTerbinafine, 4-Methyl Methoxy impurity, EE-Impurity, Impurity-2,Beta Terbinafine, Cis Isomer of Beta Terbinafine Imp-A,B,C,D,E,, Impurity-B, EP-A,B,C,D,E All EP Impurities EP-A,B,C

9 Benzoyl impurity, VardenafilCl Dimer impurity ydroxyziprasidone, Imp-A KET-IMP, Ziprasidone Alcoholimp, ydrochloride Impurity-B (USP/EP), IMP-E IMP-C (EP), IMP-D IMP-E (EP) Imidazole -1-yl acetic acid, Zoledronic acid Imidazole Desmethyl, R-Isomer, Zolmitriptan ydroxyderivative, Cyclisedimp, Ester Imp Amide impurity, Bromo, ydroxy, dimer, Methyl amine impurity, Zolpidemtartarate impuritya,cyano impurity, 3Acetic acid impurity, impurity E/3-methyl impurity, Impurity-A, impurity E/3-Methyl acetopheneone impurity 2-hydroxy acetophenoneoxime, 4-hydroxy coumarin,ammonium salt, Zonisamide 1,2-benzisonazole-3-methane sulfonic acid, S. o Batch o Impurity structure API Cas o: 1 Alpha isomer P Sofosbuvir

10 2 DImer-impurity P P 3 L-Ala dimer impurity P 4 3-isomer impurity P 5 Sofosbuvir Desphosphate impurity 6 Phosphoramidate (S) P (S) 7 Sofosbuvir Desphosphate alpha-isomer

11 Rivaroxaban Amino ethyl impurity Rivaroxaban phthalimido descarbonyl impurity Rivaroxaban phthalimido impurity Rivaroxaban Linezolid amine impurity Linezolid phthalimido descarbonyl impurity Linezolid phthalimido impurity Linezolid Linezolid Amino ethyl impurity 15 Des chloro impurity Amine Impurity 17 Chloroethyl Impurity Cl Paliperidone Quetiapine Lactam Quetiapine S

12 19 Quetiapine USP RC B Rabeprazole sulfone n- oxide 21 Rabeprazole -oxide 22 Rabeprazole Sulfide n- oxide 23 Rabeprazole chloro imp Cl 24 2-mercaptobenzimidazole 25 9-ydroxy Risperidone S S S Rabeprazole S S Risperidone )Amlodipine iso propyl analog imp 2)Atorvastatin desfluoro imp 3)Atovaquinone ep imp-a 4)Atorvastatin enantiomer imp 5)Aripiprazole imp-d 6)Aripiprazole -oxide imp 7)Almotriptan imp-a 8)Atenolol imp- 9)Atorvastatin imp-c 10)Clopidrogrel imp-b 11)Ciprofloxavin des fluoro imp(ep imp-b) 12)celecoxib ep imp-a 13)Celecoxib ep imp-b 14)Abacavir tertiory butyl derivative imp 15)Clarithromycin imp-g

13 16)Darfenacin dimer imp 17)Duloxatine USP imp-b 18)Desvenlafloxacin -oxide 19)Desvenlafloxacin 0.9 rrt imp 20)Enrofloxacin regio isomer of acrylate imp 21)Enrofloxacin des fluoro imp 22)Eletriptan dehydro acetyl imp 23)Enrofloxacin.Cl chloro analog imp 24)Enrofloxacin chloro analog imp 25)Etiroxib des chloro imp 26)Enrofloxacin des fluoro imp 27)Ezetimibe keto imp 28)Ezetimibe MPZT-1 imp 29)Ezetimibe MPZT-2 imp 30)Ezetimibe SRS imp 31)Ezetimibe 2-fluoro imp 32)Etiroxib dimer imp 33)Efavirentz ep imp-a 34)Etiroxib ep imp-b 35)rovatriptan S-ispmer imp 36)luconazole imp-b 37)luconazole imp-d 38)Itracanazole imp-e 39)Itracanazole imp- 40)Loratadine imp-b 41)Loratadine chloro imp 42)Loratadine dichloro imp 43)Loratadine dichloro keto imp 44)Losartan potassium ep imp- 45)Lomitragine ep imp-a 46)Lomitrigine ep imp-c 47)Montelukast keto imp(imp-) 48)Montelukast michal adduct 49)Milaraciptran lactone imp 50)meprazole n-methyl imp 51)Paliperidone keto imp 52)Pragabalin imp-d 53)Pentaprazole sulfone imp 54)Pioglitazine imp-c 55)Perindrofil imp-b 56)Perindrofil imp-a 57)Propafenone imp-a 58)Propafenone imp-e 59)Quatifine dimer imp 60)Quentifine S-oxide imp 61)Rasagiline(R)-1-indamine imp 62)Sildenafil ep imp-a 63)Sildenafil ep imp-b 64)Sildenafil ep imp-c 65)Sildenafil ep imp-d 66)Sildenafil ep imp-e

14 67)Sildenafil -des methyl imp 68)Sildenafil dimer imp 69)Sildenafil pyridine imp 70)Sildenafil cyclic compound 71)Sildenafil piperazine imp 72)Simvastatin imp-b 73)saltamivir W imp-c 74)lanzapine -oxide imp 75)Tamsulosin.Cl dimer imp 76)Tenofovir isopropyl imp 77)Trazadone -oxide imp 78)Telmisartan amide imp 79)Valacyclovir imp-j 80)Valacyclovir imp- 81)Residronic acid ep imp-b 82)Rizartiptan -xide imp 83)Zidovudine imp-a 84)Zidovudine imp-b 85)Zidovudine imp-d 86)Zidovudine UK imp 87)Carvedilol imp-c 88)Carvedilol imp-d 89)Dexlansoprazole methoxy imp 90)Losartan AG-2 imp 91)3-Thiophen rotigotine imp 92)Rotinovir imp- 93)Quanapril USP related imp-b 94)Ciprofloxacin imp-e 95)Lurasidine isomer-i 96)Desmethyl erthromycin imp-b 97)Montelukast ester imp 98)ebuxostat amide imp 99)ebuxostat acid imp 100)Rasagiline chloro imp