Last update :
28/02/2024
References   References 4782  
Type : Journal
Web link : https://doi.org/10.1007/s40268-023-00433-7

Research teams : Incheon - Quality Evaluation Team, Samsung Bioepis Co
Authors : Tak M, Jeong H, Yun J, Kim J, Kim S, Lee Y, Park S-J.
Title : In‑Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period.
Reference : Drugs R D ;23,4:363 - 375 2023

Level of Evidence : 
Level of evidence A+
Physical stability : 
Particle counting Protein: Size Exclusion Chromatography Protein: Dynamic Light Scattering 
Chemical stability : 
Capillary electrophoresis
Other methods : 
PH measurement 
Comments : 
Proteins: biological activity by enzymatic technique

List of drugs
InjectionEculizumab Various
Factors which affect stability Solvent Glucose 5% Induces Reduced stability
Stability in solutions Glass Sodium chloride 0,9% 5 mg/ml 2-8°C Not specified
90 Day
Biosimilar
Stability in solutions Glass Sodium chloride 0,9% 5 mg/ml 28-32°C Not specified
72 Hour
Biosimilar
Stability in solutions Glass Sodium chloride 0,45% 5 mg/ml 2-8°C Not specified
90 Day
Biosimilar
Stability in solutions Glass Sodium chloride 0,45% 5 mg/ml 28-32°C Not specified
72 Hour
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 5 mg/ml 2-8°C Not specified
90 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 5 mg/ml 28-32°C Not specified
72 Hour
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,45% 5 mg/ml 2-8°C Not specified
90 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,45% 5 mg/ml 28-32°C Not specified
72 Hour
Biosimilar

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