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1029512

USP

Amlodipine Related Compound A

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

3-Ethyl 5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate] fumarate

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About This Item

Empirical Formula (Hill Notation):
C20H23ClN2O5 · C4H4O4
CAS Number:
2138811-33-1
Molecular Weight:
522.93
UNSPSC Code:
41116107

grade

pharmaceutical primary standard

API family

amlodipine

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

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Related Categories

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.
For further information and support please go to the website of the issuing Pharmacopoeia.

Application

This USP reference standard is intended for use in specified quality tests and assays as specified in the USP compendia.
It is also used in the preparation of standard solution for the analysis of organic impurities in tablets and capsules, in accordance with the USP monographs, by liquid chromatography (LC) combined with UV detection, such as the following:
  • Amlodipine and benazepril hydrochloride capsules
  • Amlodipine and valsartan tablets
  • Amlodipine, valsartan, and hydrochlorothiazide tablets
  • Amlodipine and olmesartan medoxomil tablets
  • Amlodipine and atorvastatin tablets
In addition, it is used in the assay test of amlodipine besylate tablets by LC-UV following the USP monograph “Amlodipine Besylate Tablets”.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

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Pricing

1029501

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PHR1185

Amlodipine besylate, Pharmaceutical Secondary Standard; Certified Reference Material

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

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

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

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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