Document Detail


Stability of stock and diluted rituximab.
MedLine Citation:
PMID:  23413167     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: 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.
CONCLUSION: 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:
Yang Zhang; Lee C Vermeulen; Jill M Kolesar
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists     Volume:  70     ISSN:  1535-2900     ISO Abbreviation:  Am J Health Syst Pharm     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-15     Completed Date:  2013-10-28     Revised Date:  2014-04-16    
Medline Journal Info:
Nlm Unique ID:  9503023     Medline TA:  Am J Health Syst Pharm     Country:  United States    
Other Details:
Languages:  eng     Pagination:  436-8     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Animals
Antibodies, Monoclonal, Murine-Derived / analysis*,  chemistry*
Cattle
Drug Stability
Drug Storage / standards
Pharmaceutical Solutions / analysis,  standards
Polyvinyl Chloride / analysis,  standards
Rats
Grant Support
ID/Acronym/Agency:
P30 CA014520/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal, Murine-Derived; 0/Pharmaceutical Solutions; 0/rituximab; 9002-86-2/Polyvinyl Chloride
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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