Last update :
03/05/2024
References   References 4292  
Type : Journal
Web link : https://doi.org/10.1007/s40268-019-0264-1

Research teams : Menges - Novartis, Menges, Slovenia
Authors : Vimpolsek M, Gottar-Guillier M, Rossy E.
Title : Assessing the Extended In-Use Stability of the Infliximab Biosimilar PF-06438179/GP1111 Following Preparation for Intravenous Infusion.
Reference : Drugs R D 19: 127–140. 2019

Level of Evidence : 
Level of evidence A+
Physical stability : 
Visual examination Particle counting Protein: Size Exclusion Chromatography 
Chemical stability : 
Stability defined as 95% of the initial concentration
Capillary electrophoresis
Other methods : 
PH measurement Measurement of osmolality 
Comments : 
Proteins: biological activity by cell culture

List of drugs
InjectionInfliximab Immunosuppressant
Stability in solutions Glass Water for Injection 10 mg/ml 2-8°C Not specified
30 Day
Biosimilar
Stability in solutions Glass Water for Injection 10 mg/ml 23-27°C Not specified
14 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 0,4 mg/ml 2-8°C Not specified
30 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 0,4 mg/ml 23-27°C Not specified
30 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 4 mg/ml 2-8°C Not specified
30 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 4 mg/ml 23-27°C Not specified
30 Day
Biosimilar

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