Last update :
13/11/2024
References   References 4016  
Type : Journal
Web link : http://dx.doi.org/10.1016/j.pharma.2017.06.003

Research teams : Créteil - Henri Mondor University Hospital, Department of Pharmacy
Authors : Vieillard V, Paul M, Ibrahim T, Astier A.
Title : Extended stability of the rituximab biosimilar CT-P10 in its opened vials and after dilution and storage in polyolefin bag.
Reference : Ann Pharm Fr ; 75, 6: 420-435. 2017

Level of Evidence : 
Level of evidence A+
Physical stability : 
Protein: Size Exclusion Chromatography Turbidimetry Protein: Dynamic Light Scattering Protein: Thermal Aggregation Curve 
Chemical stability : 
Protein: ionic chromatography
Protein: ultraviolet spectrometry and second derivative
Protein: ultraviolet spectrometry
Other methods : 
PH measurement Water loss by evaporation 
Comments : 

List of drugs
injectionRituximab Anticancer drug
Stability in solutions partially used vials None 10 mg/ml 2-4°C Protect from light
28 Day
Biosimilar
Stability in solutions partially used vials None 10 mg/ml 25°C Protect from light
15 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 1 mg/ml 2-4°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 1 mg/ml 25°C Protect from light
15 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 4 mg/ml 2-4°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 4 mg/ml 25°C Protect from light
15 Day
Biosimilar

  Mentions Légales