M. Yamakage, N. Hirata, H. Saijo, J-I. Satoh, A. Namiki

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Analysis of the composition of ‘original’ and generic sevoflurane in routine use† M. Yamakage, N. Hirata, H. Saijo, J-I. Satoh, A. Namiki British Journal of Anaesthesia Volume 99, Issue 6, Pages 819-823 (December 2007) DOI: 10.1093/bja/aem296 Copyright © 2007 British Journal of Anaesthesia Terms and Conditions

Fig 1 Composition of original and generic sevoflurane products. Data are expressed as mean (sd). *P<0.05 vs water content in original sevoflurane product after 2 weeks in a bottle. †P<0.05 vs water content in generic sevoflurane product after 2 weeks in a bottle. (a) Inorganic fluoride content was constant across all groups for the generic product; no significant differences between the products were observed, n=9 each. (b) In contrast to the samples of the wet-type original product that were opened, sealed, and stored for 2 weeks, the dry-type generic product had an extremely low water content, n=3 each. The water content of the original product (wet-type) significantly decreased when injected into a vaporizer and left to stand for 3 days. (c) As for sevoflurane content, high purity was observed in both the original and the generic products, with no differences between the products and low variation, n=9 each. British Journal of Anaesthesia 2007 99, 819-823DOI: (10.1093/bja/aem296) Copyright © 2007 British Journal of Anaesthesia Terms and Conditions

Fig 2 Types and concentrations of related substances present in the original and the generic products. Data are expressed as mean (sd), n=9. SME, sevomethylether; HFIP, hexafluoroisopropanol. Original sevoflurane contained compound A, SME, and other related substances. Although the generic sevoflurane did not contain compound A or SME, it contained HFIP and other related substances. Although a large variation in content of HFIP and other related substances in the generic product was observed between different samples, no differences were observed between different groups (conditions). Total content of related substances was significantly higher (P<0.05) in the generic product than in the original product. British Journal of Anaesthesia 2007 99, 819-823DOI: (10.1093/bja/aem296) Copyright © 2007 British Journal of Anaesthesia Terms and Conditions