Document Detail

Migration of diethylhexyl phthalate from PVC bags into intravenous cyclosporine solutions.
MedLine Citation:
PMID:  15967299     Owner:  NLM     Status:  MEDLINE    
The migration of diethylhexyl phthalate (DEHP) from PVC bags into LVPS (0.9% NaCl) and LVPS with cyclosporine at concentrations of 2.5 and 0.5mg/ml was studied. PVC bags were placed in contact with these solutions and stored at 25+/-1 degrees C. They were taken for analysis each 30 min during 6 h and after this period at each 1 h until 12 h of contact. Water was used as reference, and exposed and analyzed under the same conditions. After contact, the solutions were submitted to extraction with hexane and analyzed by GC-FID. The results showed that DEHP did not migrate into water and LVPS during all the time. Also, no measurable amount of DEHP was detected during the first 3 h of contact between the PVC bag and the diluted cyclosporine solution. However, the amount of released DEHP reached a detectable level after 4 h of contact, increased until 6 h, stabilized, and increased again after 9-10 h. The 12 h of contact showed the highest DEHP levels for both cyclosporine concentrations. The DEHP migrated was 0.02-0.08% of that present in the bag.
M A Gotardo; M Monteiro
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  38     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2005 Jul 
Date Detail:
Created Date:  2005-06-21     Completed Date:  2005-09-19     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  709-13     Citation Subset:  IM    
Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, UNESP, CP 502, CEP 14801-902 Araraquara, São Paulo, Brazil.
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MeSH Terms
Chromatography, Gas
Chromatography, High Pressure Liquid
Cyclosporine / administration & dosage,  chemistry*
Diethylhexyl Phthalate / analysis*
Drug Packaging*
Immunosuppressive Agents / administration & dosage,  chemistry*
Infusions, Intravenous
Pharmaceutical Solutions
Polyvinyl Chloride / analysis*
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Pharmaceutical Solutions; 117-81-7/Diethylhexyl Phthalate; 59865-13-3/Cyclosporine; 9002-86-2/Polyvinyl Chloride

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