|
 |
| |
Perindopril |
| Chemical Name: |
1-[2-(1-Ethoxycarbonylbutylamino)propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid 2-methyl-2-propanamine |
| Structural Formula: |
 |
| Molecular Formula: |
C19H32N2O5·C4H11N |
| Brief Intro.: |
As ACE inhibitor used in the treatment of hypertension and heat failure etc. |
ITEMS
|
REQUIREMENT
|
TEST METHODS
|
Appearance
|
White crystalline powder
|
Eyeballing |
Identification |
IR |
CP2005 Version second part AddendumⅣ C |
Purity |
≥98.5% |
HPLC |
Specific optical rotation |
-66°to -69° |
CP2005 Version second part Addendum ⅥE |
Metling point |
156~158℃ |
Version second part Addendum VI C |
Residue on ignition |
≤0.1% |
CP2005 Version second part AddendumⅧ N |
Assay |
98.5~101.0%(Anhydrous substance)
|
CP2005 Version second part Addendum Ⅶ B |
Total impuritles |
≤1.0% |
HPLC |
Heavy metal |
≤20PPM |
CP2005 Version second part AddendumⅧ H |
Water |
≤1.0 % |
K.F |
|
| Packing: |
5kgs, 25kgs cardboard drum lined with double-layer plastic bag |
|
|
|
 |
|