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Analysis of B-3 desamido insulin in human insulin preparations by HPLC
Authors:C Yomota  Y Tagashira  T Miyazaki  S Okada
Affiliation:yomota@nihs.go.jp
Abstract:The content of A-21 desamido insulin (A-21 DI) and B-3 desamido insulin (B-3 DI) in human insulin preparations was measured by new RP-HPLC method using a neutral eluent (pH 6.5). Sometimes the content of B-3 DI in human insulin preparations was about two times larger than that of A-21 DI. In particular, in the case of neutral insulin injection, the content of B-3 DI has increased remarkably as the increase of total desamido content. The content of B-3 DI obtained by the new RP-HPLC method will open the new aspect of the impurity test for insulin preparations.
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