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PHR1185

Supelco

Amlodipine besylate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(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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About This Item

Empirical Formula (Hill Notation):
C20H25ClN2O5 · C6H5SO3H
CAS Number:
111470-99-6
Molecular Weight:
567.05
MDL number:
MFCD00887594
UNSPSC Code:
41116107
PubChem Substance ID:
329823196
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

SMILES string

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

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)

InChI key

ZPBWCRDSRKPIDG-UHFFFAOYSA-N

Gene Information

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

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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 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, EP (PhEur) and BP primary standards, where they are available.

Other Notes

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.

Footnote

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.

Recommended products

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.

related product

Product No.
Description
Pricing

1029501

Amlodipine besylate, United States Pharmacopeia (USP) Reference Standard

Y0000049

Amlodipine besylate, European Pharmacopoeia (EP) Reference Standard

Y0001068

Amlodipine impurity A, European Pharmacopoeia (EP) Reference Standard

Y0001069

Amlodipine impurity B, European Pharmacopoeia (EP) Reference Standard

Y0001070

Amlodipine impurity G, European Pharmacopoeia (EP) Reference Standard

Y0001067

Amlodipine for peak identification, European Pharmacopoeia (EP) Reference Standard

1029512

Amlodipine Related Compound A, United States Pharmacopeia (USP) Reference Standard

1029545

Amlodipine Related Compound D, United States Pharmacopeia (USP) Reference Standard

1029534

Amlodipine Related Compound C, United States Pharmacopeia (USP) Reference Standard

1029614

Amlodipine Related Compound K, United States Pharmacopeia (USP) Reference Standard

59872

2-[[2-[(2-Carboxybenzoyl)amino]ethoxy]methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester, reference material

51818

Diethyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate, reference material

PHR2050

Amlodipine Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2052

Amlodipine Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2051

Amlodipine Impurity B, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2053

Amlodipine Related Compound D, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2056

Amlodipine Related Compound K, Pharmaceutical Secondary Standard; Certified Reference Material

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD3025
LRAC0717
LRAC7880
P500185
LRAA9004

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Spectrophotometric and high performance liquid chromatographic determination of amlodipine besylate in pharmaceuticals
Basavaiah K, et al.
ScienceAsia, 31(1), 13-21 (2005)
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)
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
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
László Bajnok
Orvosi hetilap, 154(7), 243-247 (2013-02-12)
From the evaluated ONTARGET, ALTITUDE, ACCOMPLISH, ROADMAP, and ACCORD-BP studies a conclusion can be drawn that though microalbuminuria/proteinuria is a strong epidemiological biomarker, in interventional studies it is not necessarily a reliable surrogate endpoint as actual renal function may change
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