Abstract Stress stability testing and forced degradation were used to determine the stability of enalapril maleate EM and to find a degradation pathway for the drug.
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Stress stability testing and forced degradation were used to determine the stability of enalapril maleate EM and to find a degradation pathway for the drug. The product is delivered as supplied by the issuing Pharmacopoeia.
Reproduction of any materials from the site is strictly forbidden without permission. S S S ethoxy o,m,p-hydroxyphenyl oxobutanylamino propanoyl pyrrolidinecarboxylic acid, 2S 2S 2S ethoxyhydroxyoxophenylbutanylamino propanoyl pyrrolidinecarboxylic acid. It was found that new impurities are oxidation products: S 3-phenylpropylamino pyrrolidinyl propanone was identified as a new degradation impurity.
European Pharmacopoeia (EP) Reference Standard
All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia. Other Notes Sales restrictions may apply. General description This product is provided as delivered and specified by the issuing Pharmacopoeia.
HPLC analysis showed several degradation impurities of which several were already determined, but on oxidation in the presence of magnesium monoperoxyphthalate MMPP several impurities of EM were observed which were not yet characterized.
Documents Certificate of Analysis. The validated HPLC method was used to determine the degradation impurities in samples after stress stability testing and forced degradation of EM.
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