Amlodipine besylate
| S.NO | Impurity Name | Monograph | Chemical Name | Structure | CAS NUMBER |
|---|---|---|---|---|---|
| 1 | AmlodipineImpurityA/Related compound D | EP/USP | 3-ethyl 5-methyl (4RS)-4-(2-Chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindole-2-yl) ethoxy] methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate |  |
88150-62-3 |
| 2 | AmlodipineImpurityB | EP | 3-ethyl 5-methyl (4RS)-4-(2-Chlorophenyl)-6-methyl-2- [[2- [[2- (methyl carbamoyl) benzoyl] amino] ethoxy] methyl]-1,4-dihydropyridine-3,5-dicarboxylate |  |
721958-72-1 |
| 3 | AmlodipineImpurityD/ Related compound-A (Dehydro Amlodipine) | EP/USP | 3-ethyl 5-methyl 2-[(2-aminoethoxy) -methyl]-4-(2-chlorophenyl)-6-methyl pyridine-3,5-dicarboxylate |  |
113994-41-5 |
| 4 | AmlodipineImpurityE/ Related compound E (Amlodipine diethyl ester)/ | EP/USP | diethyl(4RS)-2-[(2-aminoethoxy) methyl] -4-(2-chlorophenyl)-6-methyl-l, 4-dihydropyridine-3,5-dicarboxylate |  |
140171-65-9 |
| 5 | AmlodipineImpurityF/Related compound-F (Dimethoxyimpurity) | EP/USP | dimethyl(4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-l,4-dihydropyridine-3,5-dicarboxylate |  |
140171-66-0 |
| 6 | AmlodipineImpurityG | EP | dimethyl-4-(2-chlorophenyl)-2,6-dimethyl-l, 4-dihydropyridine-3,5-dicarboxylate |  |
43067-01-2 |
| 7 | AmlodipineForPeak Identification | ||||
| 8 | Des chloroImpurityof Amlodipine besilate | In house | 3-ethyl 5-methyl 2-((2-aminoethoxy) methyl)-6-methyl-4-phenyl-1, 4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |  |
NA |
| 9 | R (+) Amlodipine Impurity | In house | (R)-3-Ethyl 5-methyl 2-((2-aminoethoxy) methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate |  |
828247-64-9 |
| 10 | Des chloro Impurity of Amlodipine(St-IV) | In house | 3-ethyl 5-methyl 2-((2-(1,3-dioxoisoindolin -2-yl) ethoxy) methyl)-6-methyl-4-phenyl-1,4-dihydropyridine-3,5-dicarboxylate |  |
NA |
| 11 | Dimethoxy Impurity of Amlodipine(St-IVB) | In house | dimethyl 4-(2-chlorophenyl)-2-((2-(1,3-dioxoisoindolin-2-yl)ethoxy)methyl)- 6-methyl-1,4-dihydropyridine-3,5- dicarboxylate |  |
NA |
| 12 | Dimethoxy Impurity of Amlodipine(St-II) | In house | ethyl 4-(2-(1,3-dioxoisoindolin-2-yl) ethoxy)-3-oxobutanoate |  |
88150-75-8 |
| 13 | Aspartate impurity of Amlodipine | EP | 4-(2-chlorophenyl)-2-[[2-[(1,2-dicarboxyethyl) amino] ethoxy] methyl]-1,4-dihydro-6-methyl-3,5-Pyridinedicarboxylic acid 3-ethyl 5-methyl ester |  |
400602-35-9 |
Cetirizine Di Hydrochloride |
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| 14 | Cetirizine Impurity A/ CBHP | EP/USP | (RS)-1-[(4-Chloropheny) phenylmethyl] piperazine |  |
303-26-4 |
| 15 | Cetirizine Impurity B/ Cetirizine acetic acidg | EP/USP | (RS)-2-[4-[(4-Chloropheny) phenylmethyl] piperazin-1-yl] acetic acid |  |
113740-61-7 |
| 16 | Cetirizine Impurity C/ 2-Chloro cetirizine | EP/USP | (RS)-2-[2-[4[(2-chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] acetic acid |  |
83881-59-8 |
| 17 | Cetirizine Impurity D/ Cetirizine dimer | EP/USP | 1,4-bis[(4-Chloropheny) phenylmethyl] piperazine |  |
346451-15-8 |
| 18 | Cetirizine impurity E | EP | (RS)-2-[2-[2-[4-[(4-chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] ethoxy] acetic acid |  |
682323-77-9 |
| 19 | Cetirizine Impurity F/Deschlorocetirizinea | EP/USP | 2-[2-[4-(diphenylmethyl) piperazin-1-yl] ethoxy] acetic acid |  |
83881-53-2 |
| 20 | Cetirizine Impurity G/ Cetirizine ethanol | EP/USP | (RS)-2-[4-[(4-chlorophenyl) phenylmethyl] piperazin-1-yl] ethan-1-ol |  |
164726-80-1 |
| 21 | METHYL ESTER OF CETIRIZINE (IMPURITY – E, As per USP) | USP | Methyl 2-[2-[4-[(4-chlorophenyl) phenyl methyl]-1-piperazinyl] ethoxy] acetate |  |
83881-46-3 |
| 22 | 3- CHLORO IMPURITY OF CETIRZINE (IMPURITY – F, As per USP) | USP | 2-[2-[4-[(3-Chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid |  |
1232460-29-5 |
| 23 | PARACHLORO BENZHYDROL (IMPURITY – I, As per USP) | USP | 4-chloro benzhydrol |  |
119-56-2 |
| 24 | Para Chloro Benzo Phenone (IMPURITY – J, As per USP) | USP | (4-chlor phenyl) phenyl methanone |  |
134-85-0 |
| 25 | Cetirizine N-Oxide (IMPURITY – H, As per USP) | USP | 2-(2-{4-[(4-chlorophenyl) (phenyl) methyl] piperazin-1-yl} ethoxy) acetic acid N-oxide |  |
1076199-80-8 |
| 26 | Chloro pheniramine maleate | ||||
| 27 | Cetirizine for peak identification | ||||
Working Standard’s |
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| 28 | Amlodipine Besilate | EP/USP | 3-ethyl 5-methyl(4RS)- 2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |  |
111470-99-6 |
| 29 | Amlodipine Besilate P-III EP | EP | 3-ethyl 5-methyl(4RS)- 2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |  |
111470-99-6 |
| 30 | Amlodipine Besilate IP | IP | 3-ethyl 5-methyl(4RS)- 2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |  |
111470-99-6 |
| 31 | Amlodipine Besilate P-III (USP) | USP | 3-ethyl 5-methyl(4RS)- 2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |  |
111470-99-6 |
| 32 | Amlodipine Besilate JP | JP | 3-ethyl 5-methyl(4RS)- 2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |  |
111470-99-6 |
| 33 | Amlodipine Maleate | 3-ethyl 5-methyl 2-((2-aminoethoxy) methyl) -4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate maleate |  |
88150-47-4 | |
| 34 | S (-) Amlodipine Besilate | IP | (4S)-2-[(2-Aminoethoxy) methyl]-4- (2-chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester benzene sulfonate |  |
150566-71-5 |
| 35 | Cetirizine Di Hydrochloride (EP) | EP | 2-(2-(4-((4-chlorophenyl) (phenyl) methyl) piperazin-1-yl) ethoxy) acetic acid |  |
83881-52-1 |
| 36 | Cetirizine Di Hydrochloride (USP) | USP | 2-(2-(4-((4-chlorophenyl) (phenyl) methyl) piperazin-1-yl) ethoxy) acetic acid |  |
83881-52-1 |
| 37 | Amlodipine Besilate St-I (Phthalimido Ethanol) | In house | 2-(2-hydroxyethyl) isoindoline-1,3-dione |  |
3891-07-4 |
| 38 | Amlodipine Besilate St-II | In house | ethyl 4-(2-(1,3-dioxoisoindolin-2-yl) ethoxy) -3-oxobutanoate |  |
88150-75-8 |
| 39 | Amlodipine Besilate St-III | In house | (E)-ethyl 2-(2-chlorobenzylidene)-4-(2-(1,3-dioxoisoindolin-2-yl) ethoxy)-3-oxobutanoate |  |
NA |
| 40 | Amlodipine Besilate St-IV(A) | In house | 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-((2- (1,3-dioxoisoindolin-2-yl) ethoxy) methyl) -6-methyl-1,4-dihydropyridine-3,5- dicarboxylate |  |
88150-62-3 |
| 41 | Amlodipine Besilate St-IV(B) | In house | 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-((2- (1,3-dioxoisoindolin-2-yl) ethoxy) methyl)- 6-methyl-1,4-dihydropyridine-3,5- dicarboxylate |  |
88150-62-3 |
| 42 | Amlodipine Base In-house Primary reference standard | In house | 3-ethyl 5-methyl 2-((2-aminoethoxy) methyl) -4-(2-chlorophenyl)-6-methyl-1,4- dihydropyridine-3,5-dicarboxylate |  |
88150-42-9 |
| 43 | Iloperidone In-house Primary reference standard | ||||
| 44 | Levocetirizine di HCl IH/USP | USP | (S)-2-(2-(4-((4-chlorophenyl) (phenyl)methyl) piperazin-1-yl) ethoxy) acetic acid |  |
130018-87-0 |
Raloxifene HCl |
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| 45 | 3,7-Diketo impurity (Impurity-I) | USP | (6-hydroxy-2-(4-hydroxyphenyl) benzo[b] thiophene-3,7-diyl) bis((4-(2-(piperidin-1-yl) ethoxy) phenyl) methanone) |  |
1159977-58-8 |
| 46 | Raloxifene Impurity-C (N-Oxide) | USP | 1-(2-(4-(6-hydroxy-2-(4-hydroxyphenyl) benzo[b] thiophene-3-carbonyl) phenoxy) ethyl) piperidine 1-oxide |  |
195454-31-0 |
| 47 | Raloxifene Impurity-H | USP | 4-(2-(piperidin-1-yl) ethoxy) benzoic acid hydrochloride |  |
84449-80-9 |
| 48 | Raloxifene (Dimethoxy Impurity) | USP | (6-methoxy-2-(4-methoxyphenyl) benzo[b] thiophen-3-yl) (4-(2-(piperidin-1-yl) ethoxy) phenyl) methanone |  |
84541-38-8 |
Clopidogrel bisulfate |
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| 49 | Impurity-A | EP/USP | (2S)-2-(2-chlorophenyl)-2- [6,7-dihydrothieno [3,2-c] pyridin-5(4H)-yl] acid |  |
144457-28-3 |
| 50 | Impurity-B | EP/USP | Methyl (2S)- (o-chlorophenyl) [4,5-dihydrothieno[2,3-c] pyridine-6 (7H)-yl] acetate |  |
1396841-05-6 |
| 51 | Impurity-C | EP/USP | Clopidogrel Bisulfate R-Isomer; Methyl (-) -(R) -(o-chlorophenyl) [6,7-dihydrothieno [3,2-c] pyridine-5(4H)-yl] acetate hydrogen sulfate |  |
120202-71-3 |
| 52 | Impurity-D | EP | Methyl (2R)- (2-chlorophenyl) [(2S)- (2-chlorophenyl) [6,7-dihydrothieno [3,2-c] pyridin-5(4H)-yl] acetyloxy] acetate. |  |
1421283-60-4 |
| 53 | Impurity-E Clopidogrel Amide Racemate | EP | (2RS)-2-(2-chlorophenyl)-2- [6,7-dihydrothieno[3,2-c] pyridin-5 (4H)-yl] acetamide |  |
90055-68-8 |
| 54 | Impurity-F Thienylethyl Impurity | EP | methyl (S)-2-(2-chlorophenyl)-2-((2-(thiophen-2-yl) ethyl) amino) acetate hydrochloride |  |
141109-19-5 |
| 55 | Clopidogrel Related Compound B | USP | Methyl (±)-(o-chlorophenyl)[4,5-dihydrothieno[2,3-c]pyridine-6(7H)-yl]acetate hydrochloride |  |
144750-52-7 |
