1029512

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
• Empirical Formula (Hill Notation): C₂₀H₂₃ClN₂O₅ · C₄H₄O₄
• CAS Number: 2138811-33-1
• Molecular Weight: 522.93
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: amlodipine
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C

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.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable