Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection

Category: Special Report
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Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Abstracts:
The physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after reconstitution with cold water for injection (WFI) and storage in original glass vials and polypropylene (PP) syringes at different temperatures. At 2°C‒8°C, stability was observed for 3 days in both containers. At -20°C, stability was maintained for 60 days regardless of container type. These findings support refrigerated storage for 72 hours and frozen storage for prolonged stability. Minimizing exposure to room temperature is crucial to maintain efficacy during handling and transportation.

Submitted: 4 March 2024; Revised: 15 April 2024; Accepted: 26 April 2024; Published online first: 6 May 2024

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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