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Merck

PHR1185

Amlodipine besylate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

(4R, S)-3-Ethyl-5-methyl 2-(2-amino-ethoxy-methyl)-4-(2-chlorophenyl)-1,4-dihydroxy-6-methyl pyridine-3,5-dicarboxylate monobenzene sulphonate, 2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzene sulfonate, Norvasc

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A propos de cet article

Formule empirique (notation de Hill) :
C20H25ClN2O5 · C6H5SO3H
Numéro CAS:
111470-99-6
Poids moléculaire :
567.05
NACRES:
NA.24
PubChem Substance ID:
329823196
UNSPSC Code:
41116107
MDL number:
MFCD00887594

Principaux documents

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InChI

1S/C20H25ClN2O5.C6H6O3S/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21;7-10(8,9)6-4-2-1-3-5-6/h5-8,17,23H,4,9-11,22H2,1-3H3;1-5H,(H,7,8,9)

SMILES string

OS(=O)(=O)c1ccccc1.CCOC(=O)C2=C(COCCN)NC(C)=C(C2c3ccccc3Cl)C(=O)OC

InChI key

ZPBWCRDSRKPIDG-UHFFFAOYSA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000049, traceable to USP 1029501

API family

amlodipine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

Gene Information

human ... CACNA1C(775), CACNA1D(776), CACNA1F(778), CACNA1S(779)

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Catégories apparentées

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Amlodipine besylate is a calcium channel blocker, which inhibits the trans membrane influx of calcium ions into vascular smooth muscles and cardiac muscle. It belongs to the dihydropyridine family. It is used in combination with atorvastatin calcium to treat vasospastic angina, chronic stable angina, hypertension, in elevated serum triglyceride levels, primary dysbetalipoproteinemia.

Application

Amlodipine besylate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using different chromatography techniques and spectrophotometric technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Amlodipine besylate is an L-type calcium channel blocker.
Amlodipine is an L-type calcium channel blocker. Amlodipine belongs to a class of cardiovascular drugs, which act at the voltage gated calcium channel of the CaV1, or L-type, class. Amlodipine also has antihypertensive and antianginal effects. Its activity resides mainly in the (-)-isomer. Amlodipine inhibits growth of human epidermoid carcinoma A431 cells and has antireproductive effects in male rats.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAC0717 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Classe de stockage

11 - Combustible Solids

wgk

WGK 3

Certificats d'analyse (COA)

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Consulter la Bibliothèque de documents

Spectrophotometric and high performance liquid chromatographic determination of amlodipine besylate in pharmaceuticals
Basavaiah K, et al.
ScienceAsia, 31(1), 13-21 (2005)
Giuseppe Derosa et al.
Journal of the American Society of Hypertension : JASH, 7(1), 32-39 (2013-01-17)
The purpose of this study was to evaluate a fixed olmesartan/amlodipine combination on blood pressure control, lipid profile, insulin sensitivity, and some inflammatory markers compared with single-drug monotherapy. A total of 276 hypertensive patients were randomly assigned to olmesartan 20
Juliano Lara Fernandes et al.
The American journal of medicine, 126(9), 834-837 (2013-07-09)
Iron chelation therapy in patients with thalassemia major may not prevent iron overload in all organs, especially those in which iron enters cells through specific calcium channels. We designed a controlled pilot study to assess the potential of the calcium
Stability indicating RP-HPLC estimation of atorvastatin calcium and amlodipine besylate in pharmaceutical formulations
Shah AD, et al.
Indian Journal of Pharmaceutical Sciences, 70(6), 754-754 (2008)
Mehmet Gumustas et al.
Journal of AOAC International, 96(4), 751-757 (2013-09-05)
A stability-indicating RP-LC assay method was developed for the simultaneous determination of the cardiovascular drugs amlodipine and perindopril in the presence of degradation products generated from forced decomposition studies. The developed method is applicable for the determination of related substances
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