PHR1887

Perindopril erbumine

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Perindopril erbumine, (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-1H-indole-2-carboxylic acid tert-butylamine salt, Perindopril tert-butylamine, S-9490
• Empirical Formula (Hill Notation): C₁₉H₃₂N₂O₅ · C₄H₁₁N
• CAS Number: 107133-36-8
• Molecular Weight: 441.60
• MDL number: MFCD02313824
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 1073; traceable to Ph. Eur. Y0000238; traceable to USP 1510889
• API family: perindopril
• form: solid
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• application(s): pharmaceutical
• storage temp.: 2-8°C
• SMILES string: CC(C)(C)N.CCC[C@H](N[C@@H](C)C(=O)N1[C@H]2CCCC[C@H]2C[C@H]1C(O)=O)C(=O)OCC
• InChI: 1S/C19H32N2O5.C4H11N/c1-4-8-14(19(25)26-5-2)20-12(3)17(22)21-15-10-7-6-9-13(15)11-16(21)18(23)24;1-4(2,3)5/h12-16,20H,4-11H2,1-3H3,(H,23,24);5H2,1-3H3/t12-,13-,14-,15-,16-;/m0./s1
• InChI key: IYNMDWMQHSMDDE-MHXJNQAMSA-N
• Gene Information: human ... ACE(1636)

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

Application

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

Perindopril erbumine is an angiotensin converting enzyme (ACE) inhibitor; antihypertensive; becomes hydrolyzed in vivo to the active diacid metabolite; unlike the other ACE inhibitors, inhibits tumor growth in hepatocellular carcinoma cells due to suppression of VEGF levels; also suppresses angiotensin II production in vitro. Long-term therapy with this agent has a beneficial effect on the cerebral circulation by improving cerebral perfusion reserve in patients with previous minor stroke.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAB0641 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H361d
• Precautionary Statements: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable