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PHR2050

Supelco

Amlodipine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

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:
Molecular Weight:
522.93
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1029512

API family

amlodipine

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

application(s)

pharmaceutical small molecule

format

neat

storage temp.

2-8°C

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General description

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.

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.

It is an impurity of the long-acting calcium channel blocker, amlodipine, that belongs to the class of 1,4-Dihydropyridine (DHP) calcium antagonists. The parent active pharmaceutical ingredient is used in the treatment of hypertension and anginal chest pain.

Application

This pharmaceutical secondary standard can also be used as follows:

  • Development of a stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method for determining related impurities of S(−)amlodipine and S(−)metoprolol succinate in their combined tablet dosage
  • Ultra-high pressure liquid chromatographic (UHPLC) separation and estimation of amlodipine and bisoprolol-related impurities in the combined pharmaceutical formulation of the parent APIs
  • Development and validation of a UHPLC method for quantifying impurities of valsartan, amlodipine besylate, and hydrochlorothiazide in their combined tablet dosage
  • Separation and determination of amlodipine and atorvastatin, along with their impurities using a stability-indicating RP-HPLC method in their combined solid dosage forms

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB9841 in the Documents 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

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1 - STOT RE 2

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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Robust UHPLC separation method development for multi-API product containing amlodipine and bisoprolol: the impact of column selection
Kormany, R, et al.
Chromatographia, 77, 1119-1127 (2014)
Stability-indicating method for the determination of assay and quantification of impurities in amlodipine-atorvastatin combination dosage form by RP-HPLC
Sangeetha D and Vadlamudi MK
Journal of Liquid Chromatography and Related Technologies, 40, 576-598 (2017)
Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S (-) Amlodipine and S (-) Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form
Shitole S, et al.
Chromatography Research International, 2014 (2014)

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