Last update :
20/01/2021
References   References 4493  
Type : Journal

Research teams : Créteil - Henri Mondor University Hospital, Department of Pharmacy
Authors : Le Guyader G, Vieillard V, Paul M.
Title : Physicochemical stability study of MYL-1401O, a biosimilar of trastuzumab, following a transient temperature excursion.
Reference : J Oncol Pharm Practice 2020

Level of Evidence : 
Level of evidence A+
Physical stability : 
Turbidimetry Protein: Size Exclusion Chromatography Protein: Dynamic Light Scattering 
Chemical stability : 
Protein: ionic chromatography
Protein: ultraviolet spectrometry and second derivative
Protein: intrared spectrometry and second derivative
Ultraviolet spectrometry
Other methods : 
PH measurement 
Comments : 

List of drugs
InjectionTrastuzumab Anticancer drug
Stability in solutions Glass Water for Injection 21 mg/ml 4°C Protect from light
30 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 0.8 & 2.4 mg/ml 25°C Not specified
3 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 0.8 & 2.4 mg/ml 4°C Not specified
90 Day
Biosimilar

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