PHR2050
Amlodipine Related Compound A
Pharmaceutical Secondary Standard; Certified Reference Material
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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
Recommended Products
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.
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.
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Product No.
Description
Pricing
Signal Word
Danger
Hazard Statements
Precautionary 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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Find documentation for the products that you have recently purchased in the Document Library.
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)
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)
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)
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