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USP

Amlodipine Related Compound A

United States Pharmacopeia (USP) Reference Standard

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Synonym(s):
3-Ethyl 5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate] fumarate
Empirical Formula (Hill Notation):
C20H23ClN2O5 · C4H4O4
CAS Number:
Molecular Weight:
522.93
UNSPSC Code:
41116107
NACRES:
NA.24

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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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.

related product

Product No.
Description
Pricing

WGK

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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Amlodipine and Atorvastatin Tablet
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(2), 265-265 (2020)
Amlodipine and Benazepril Hydrochloride Capsules
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 45(3), 269-269 (2020)
Amlodipine and Olmesartan Medoxomil Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 44(2), 272-272 (2021)
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(2), 279-279 (2017)
Amlodipine and Valsartan Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(2), 275-275 (2017)

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