|
Subject: isopropyl acetonide atorvastatin pharma. Пожалуйста, помогите перевести следующую фразу:Source:
Ethyl acetonide atorvastatin is the ethyl analogue of the final isolated intermediate, *isopropyl acetonide atorvastatin* (IAA, PF-04994265).
It is formed by the reaction of ethanol (from hydrolysis of residual ethyl acetate) with phthalimido-lactone in the esterification reaction and subsequent reaction of this ethyl ester under the process conditions.
Observed Range in IAA:
Typical levels not detected - 0.11% area
Observed Range in Drug Substance:
Typically not detected.
Discussion:
The ethyl ester hydrolyzes to the acid under the same conditions as the isopropyl ester resulting in the formation of atorvastatin calcium.
Ethyl Acetonide Atorvastatin (EAA, PF-05077991) will be captured under unknown impurities in the drug substance with a specification of NMT 0.1% area.
|