PHR1289

Enalapril Maleate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Enalapril maleate salt, (S)-N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-Ala-Pro maleate salt
• Empirical Formula (Hill Notation): C₂₀H₂₈N₂O₅ · C₄H₄O₄
• CAS Number: 76095-16-4
• Molecular Weight: 492.52
• EC Number: 278-375-7
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 741; traceable to Ph. Eur. E0109000; traceable to USP 1235300
• 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
• 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
• 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
• InChI key: UQKQUZOIQFOJOI-KJHLASMFSA-N

Description

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.[1]

Application

Enalapril Maleate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[2][1] using derivative UV spectrophotometry[2] and chromatography techniques.[2][1]

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.

Analysis Note

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

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.

Footnote

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.

Safety Information

• pictograms: GHS08
• signalword: Warning
• hcodes: H361fd
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 2
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 2