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1029512

USP

Amlodipine Related Compound A

Name: Amlodipine Related Compound A
Brand: USP

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

MDL number:

MFCD28122980

UNSPSC Code:

41116107

NACRES:

NA.24

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Properties

grade

pharmaceutical primary standard

API family

amlodipine

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

Clc1c(cccc1)c2c(c(nc(c2C(=O)OC)C)COCCN)C(=O)OCC.OC(=O)\C=C\C(=O)O

InChI

1S/C20H23ClN2O5.C4H4O4/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;5-3(6)1-2-4(7)8/h5-8H,4,9-11,22H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1+

InChI key

BWAQLJHPVPAANJ-WLHGVMLRSA-N

Description

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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Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Amlodipine, Valsartan, and Hydrochlorothiazide Tablets

USP43-NF38: United States Pharmacopeia and National Formulary

United States Pharmacopeia, 43(2), 279-279 (2017)

Global Trade Item Number

SKU	GTIN
1029512-25MG	04061835345892