title: Stability of stock and diluted rituximab.
abstract: OBJECTIVE
  The stability of two rituximab preparations stored in polyvinyl chloride (PVC) bags at 4 °C for up to 14 days was investigated.
  
  
  METHODS
  Two types of test samples were prepared: (1) 10 mL of rituximab solution (10 mg/mL) drawn directly from the original manufacturer's vial and injected into sterile glass vials and (2) 3 mL of rituximab 10 mg/mL mixed with 17 mL of 0.9% sodium chloride injection and injected into sterile PVC bags. Samples were analyzed immediately after preparation and after storage at 4 °C for 3, 7, and 14 days. Rituximab activity at the designated time points was measured using a validated enzyme-linked immunosorbent assay (ELISA) method. Chemical stability was defined as the retention of ≥85% of the drug's initial activity. Physical stability was evaluated through visual inspection for color changes or precipitate formation under normal laboratory lighting.
  
  
  RESULTS
  The results of ELISA testing (with spectrophotometric absorbance assessment) indicated that the percentage of initial rituximab activity retained was over 85% for both test preparations under the storage conditions evaluated; no changes in color or turbidity were observed in any of the test samples. These findings suggest that extending the expiration dating of both stock and diluted rituximab solutions beyond the manufacturer-specified limit of 24 hours is feasible.
  
  
  CONCLUSIONS
  Rituximab 10 mg/mL undiluted in glass vials and 1.5 mg/mL diluted in 0.9% sodium chloride injection in PVC bags are stable at 4 °C for up to 14 days.
authors: Division of Pharmacy Practice, School of Pharmacy, University of Wisconsin (UW)- Madison, 53705, USA.
authors: Yang
authors: Y
authors: Zhang
authors: Lee C
authors: LC
authors: Vermeulen
authors: Jill M
authors: JM
authors: Kolesar
mesh_terms: D000818:Animals; D058846:Antibodies, Monoclonal, Murine-Derived / Q000032:analysis* / Q000737:chemistry*; D002417:Cattle; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards; D019999:Pharmaceutical Solutions / Q000032:analysis / Q000592:standards; D011143:Polyvinyl Chloride / Q000032:analysis / Q000592:standards; D051381:Rats; D000069283:Rituximab
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D019999:Pharmaceutical Solutions; D000069283:Rituximab; D011143:Polyvinyl Chloride