Process for the preparation of epoprostenol sodium of enhanced stability

Process for the preparation of epoprostenol sodium of enhanced stability

The present invention provides stable epoprostenol sodium drug substance which can be stored in deep freezer (-20 ± 5 DEG C) for at least 3 years, characterized by that the lyophilized drug substance contains epoprostenol sodium salt and, related to the amount of the epoprostenol sodium salt, it con...

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Hauptverfasser: TORMASI, ROBERTNE, KARDOS, ZSUZSANNA, MOLNAR, JOZSEF, HORTOBAGYI, IREN, TAKACS, LASZLO, LASZLOFI, ISTVAN
Format: Patent
Sprache:chi ; eng
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HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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creator TORMASI, ROBERTNE
KARDOS, ZSUZSANNA
MOLNAR, JOZSEF
HORTOBAGYI, IREN
TAKACS, LASZLO
LASZLOFI, ISTVAN
description The present invention provides stable epoprostenol sodium drug substance which can be stored in deep freezer (-20 ± 5 DEG C) for at least 3 years, characterized by that the lyophilized drug substance contains epoprostenol sodium salt and, related to the amount of the epoprostenol sodium salt, it contains in 3-7.5 mass% inorganic base or basic-hydrolyzing inorganic salt.
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
title Process for the preparation of epoprostenol sodium of enhanced stability
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