In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged Storage at Room Temperature Conditions

These data show that the physicochemical and biological quality of SDZ-RTX diluted in 0.9% NaCl infusion bags is assured, even after prolonged worst-case (out-of-fridge and in-use) storage at elevated temperatures up to 30 °C, if the medication is prepared under aseptic conditions according to the Summary of Product Characteristics.

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Publication Details

Journal
Drugs in R&D
Published
2024-11-19
DOI
https://doi.org/10.1007/s40268-024-00496-0
Citations
1
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.24
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article

In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged Storage at Room Temperature Conditions

André Mischo, Roman Borišek, Tobias Foierl
1 citations
Drugs in R&D
Biosimilars and Bioanalytical Methods
0.24
article

In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged Storage at Room Temperature Conditions

André Mischo, Roman Borišek, Tobias Foierl
article en
1 citations

Abstract

These data show that the physicochemical and biological quality of SDZ-RTX diluted in 0.9% NaCl infusion bags is assured, even after prolonged worst-case (out-of-fridge and in-use) storage at elevated temperatures up to 30 °C, if the medication is prepared under aseptic conditions according to the Summary of Product Characteristics.

Drugs in R&DVol. 24(4)
Novartis (Switzerland) (CH), Novartis (Slovenia) (SI), Novartis (Austria) (AT)
Openalex Percentile: Top 40%
Biosimilars and Bioanalytical Methods
0.24
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