Last update :
19/11/2024
References   References 4191  
Type : Journal
Web link : http://gabi-journal.net/extended-stability-of-a-biosimilar-of-trastuzumab-ct-p6-after-reconstitution-in-vials-dilution-in-polyolefin-bags-and-storage-at-various-temperatures.html

Research teams : Créteil - Henri Mondor University Hospital, Department of Pharmacy
Authors : Vieillard V, Astier A, Paul M.
Title : Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at varioustemperatures.
Reference : GaBI Journal 2018

Level of Evidence : 
Level of evidence A+
Physical stability : 
Turbidimetry Protein: Size Exclusion Chromatography Protein: Dynamic Light Scattering Microscopic examination 
Chemical stability : 
Protein: ionic chromatography
Protein: intrared spectrometry and second derivative
Other methods : 
Measurement of osmolality 
Comments : 

List of drugs
injectionTrastuzumab Anticancer drug
Stability in solutions partially used vials Water for Injection 21 mg/ml 2-5°C Protect from light
90 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 0,8 & 2,4 mg/ml 2-5°C Protect from light
90 Day
Biosimilar

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