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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Bibliographische Detailangaben
Hauptverfasser: TORMASI, ROBERTNE, KARDOS, ZSUZSANNA, MOLNAR, JOZSEF, HORTOBAGYI, IREN, TAKACS, LASZLO, LASZLOFI, ISTVAN
Format: Patent
Sprache:chi ; eng
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Zusammenfassung: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.