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Merck

PHR1289

Enalapril Maleate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Enalapril maleate salt, (S)-N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-Ala-Pro maleate salt

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About This Item

Empirical Formula (Hill Notation):
C20H28N2O5 · C4H4O4
CAS Number:
76095-16-4
Molecular Weight:
492.52
NACRES:
NA.24
UNSPSC Code:
41116107
EC Number:
278-375-7

Key Documents

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Product Name

Enalapril Maleate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

UQKQUZOIQFOJOI-KJHLASMFSA-N

InChI

1S/C21H30N2O5.C4H4O5/c1-3-28-19(24)14-17(12-11-16-8-5-4-6-9-16)22-15(2)20(25)23-13-7-10-18(23)21(26)27;5-3(6)1-2-4(7)9-8/h4-6,8-9,15,17-18,22H,3,7,10-14H2,1-2H3,(H,26,27);1-2,8H,(H,5,6)/b;2-1-/t15-,17-,18-;/m0./s1

SMILES string

C[C@@H](C(N1[C@H](C(O)=O)CCC1)=O)N[C@H](CC(OCC)=O)CCC2=CC=CC=C2.O=C(OO)/C=C\C(O)=O

grade

certified reference material
pharmaceutical secondary standard

agency

USP 1235300
traceable to Ph. Eur. E0109000

API family

enalapril

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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Analysis Note

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

Application

Enalapril Maleate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using derivative UV spectrophotometry and chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

A long-acting angiotensin-converting enzyme inhibitor.

General description

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. Enalapril Maleate is a drug, which is widely used as an antihypertensive and a vasodilator in congestive heart failure. It is a derivative of 2 amino acids such as L-alanine and L-proline.

Other Notes

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.
To see an example of a Certificate of Analysis for this material enter LRAC3898 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H361fd

Hazard Classifications

Repr. 2

Storage Class

11 - Combustible Solids

wgk

WGK 2

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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Determination of hydrochlorothiazide and enalapril maleate in tablet formulations by reversed-phase HPLC
Al-Momani GI
Turkish Journal of Chemistry, 25(1), 49-54 (2001)
Simultaneous determination of enalapril maleate and hydrochlorothiazide in tablets by derivative UV spectrophotometry and high-performance liquid chromatography
Carlucci G, et al.
International Journal of Pharmaceutics, 93(1-3), 245-248 (1993)
Changhyun Lee et al.
Life sciences, 95(1), 29-39 (2013-11-19)
Enalapril, an angiotensin-converting enzyme (ACE) inhibitor, has pleiotropic effects such as anti-inflammatory effects. This study investigated the effect of enalapril on the nuclear factor-kappa B (NF-κB) pathway and on experimental colitis. The human intestinal epithelial cell (IEC) line COLO 205
Eran Leshem-Rubinow et al.
Mayo Clinic proceedings, 87(12), 1189-1195 (2012-11-13)
To investigate whether treatment initiated with an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB) for patients with ischemic heart disease, hypertension, or diabetes causes a reduction in hemoglobin (Hb) levels. This was a retrospective cohort analysis
Donald E Stull et al.
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 16(1), 164-176 (2013-01-23)
To present a step-by-step example of the examination of heterogeneity within clinical trial data by using a growth mixture modeling (GMM) approach. Secondary data from a longitudinal double-blind clinical drug study were used. Patients received enalapril or placebo and were
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