Amlodipine Besylate Related Compounds & Impurities

Amlodipine Besylate is a long-acting dihydropyridine calcium channel blocker, one of the most widely prescribed first-line therapies for hypertension and chronic stable angina globally.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Amlodipine Besylate reference standards, pharmacopeial and non-pharmacopeial Amlodipine Besylate impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Amlodipine Besylate-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Amlodipine
Amlodipine Besylate
Amlodipine Maleate
Amlodipine Orotate
Amlodipine Mesylate
Amlodipine Besylate EP Impurity A
Amlodipine Azido Analog
Amlodipine Besylate EP Impurity D (Fumarate)
Amlodipine Besylate EP Impurity D (Besylate)
Amlodipine EP Impurity D Mesylate
Amlodipine EP Impurity D (Oxalate salt)
Amlodipine Besylate EP Impurity D
Amlodipine Besylate EP Impurity B
Amlodipine EP Impurity C
Amlodipine EP Impurity E (Besylate salt)
Amlodipine Besylate EP Impurity E
Amlodipine Besylate EP Impurity F
Amlodipine EP Impurity F (Besylate salt)
Amlodipine Besylate EP Impurity G
Amlodipine Besylate EP Impurity H
Benzene Sulphonic Acid
Amlodipine N-Lactoside
Amlodipine N-Lactoside
Amlodipine Galactose Adduct
(S)-Amlodipine Besylate Dihydrate
Amlodipine EP Impurity A
(R)-Amlodipine
Amlodipine Impurity 5
N,N`-bis-(2-hydroxyethyl)phthaloyldiamide
3-O-Desethyl-5-O-desmethyl Amlodipine
3-O-Desmethyl Amlodipine
5-O-Desethyl Amlodipine
Amlodipine 4-chloro Isomer
N-Fomyl Amlodipine
Amlodipine Mannitol Adduct
Amlodipine Mannitol Adduct Acetate Salt
Amlodipine 2-Phthalimide
Deschloro Amlodipine
Amlodipine Impurity 37
Amlodipine Acetyl Impurity
Amlodipine Impurity 21
Amlodipine Besylate EP Impurity E (Maleate )
Amlodipine Impurity 23
Amlodipine Aspartic Acid Impurity
Amlodipine Related Compound K
Amlodipine Impurity 24
Amlodipine Impurity 9
Amlodipine Impurity 1
2-[(2-Chlorophenyl)methylene]-4-[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]-3-oxobutanoic Acid Ethyl Ester
O-Des[2-aminoethyl]-O-carboxymethyl dehydroamlodipine
Amlodipine Impurity 41
4-Methoxybenzene-1,2-diamine hydrochloride
Amlodipine Impurity 33
5-ethyl-7-methyl-6-(2-chlorophenyl)-8-methyl-3,4,6,8a-tetrahydro-2H-benzo[b][1,4]oxazine-5,7-dicarboxylate
9-Ethyl-7-Methyl-8-(2-Chlorophenyl)-6-methyl-3,4,8,9-tetrahydropyrido[2,1-c][1,4]oxazine-7,9-dicarboxylate
Amlodipine Impurity 31
N-Nitroso Amlodipine
Nitroso Phthaloyl Amlodipine
R-amlodipine Besylate Salt
(E)-Ethyl-2-(2-Chlorobenzylidene)-4-(1,3-dioxoisoindolin-2-yl)-3-oxobutanoate
Amlodipine Lactone Impurity
Amlodipine besylate Dihydrate
Amlodipine Impurity 28
Hydroxyethyl Phthalyl Amlodipine
Almotriptan Impurity 1
Amlodipine Mannitol Adduct Hydrochloride
Amlodipine N-Lactoside -Single Isomer disulfonate
Amlodipine Glucose + Galactose adduct
Amlodipine Impurity 8
N-Nitroso Levamlodipin
Amlodipine Glycolic Adduct
Deschloro Amlodipine Hydrochloride
Amlodipine Impurity 45
Amlodipine Impurity 44
Amlodipine Impurity 46
Amlodipine Impurity 47
N-Nitroso Amlodipine EP Impurity F
N-Nitroso Amlodipine EP Impurity E
N-Nitroso Amlodipine EP Impurity B
Amlodipine Besilate Impurity 1
Amlodipine Impurity 50
Amlodipine EP Impurity D hydrochloride
Amlodipine Impurity 51
Amlodipine Impurity 52
Amlodipine Impurity 54
Amlodipine Impurity 54
Deschloro Phthalimido Amlodipine
Amlodipine Impurity 55
Amlodipine Impurity 55
Amlodipine Methyl Ester
Amlodipine Di-Phthalimide Impurity
Benzenesulfonate
Amlodipine Impurity 56
Amlodipine Impurity 57
N-Nitroso Amlodipine Impurity-1
Amlodipine Impurity 10
Amlodipine Impurity 11
Amlodipine Impurity 12
Amlodipine Impurity 16
Amlodipine Impurity 17
Amlodipine Impurity 20
Amlodipine Impurity 3
Amlodipine Impurity 4
Amlodipine Impurity 7
Amlodipine Metabolite 5
Amlodipine N-Glucose
Levamlodipine Besylate
Amlodipine Impurity 10
Amlodipine Impurity 6
Amlodipine Dimer Impurity
Amlodipine impurity 2
Amlodipine Besylate Impurity 1
Amlodipine Impurity 13
Amlodipine Mesylate monohydrate
Benzenesulfonate Impurity
Dehydro Amlodipine N-oxide
Amlodipine Impurity 14

Metabolites

Amlodipine Dimethyl Ester Maleate
Deschloro Amlodipine Maleate
Levamlodipine Besylate Hemipentahydrate
Levamlodipine M4 Metabolite Sodium

Isotope Labelled Compounds

R-Amlodipine-D4
Amlodipine-D4 Maleate
(S)-Amlodipine-d4
Amlodipine-D4