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. 2006 Sep;23(9):2141-8.
doi: 10.1007/s11095-006-9053-y. Epub 2006 Aug 9.

Chemical analysis of solid-state irradiated human insulin

Hélène Terryn  1 , Jean-Paul Vanhelleputte, Aubert Maquille, Bernard Tilquin
Affiliations

Chemical analysis of solid-state irradiated human insulin

Hélène Terryn et al. Pharm Res. 2006 Sep.

Abstract

Purpose: To study the chemical modifications induced upon irradiation of solid human insulin at radiosterilization doses and investigate the influence of the absorbed dose on radiolysis.

Materials and methods: Volatile radiolytic products were monitored by gas chromatography coupled with mass spectrometry (GC-MS) and non-volatile products by two different high performance liquid chromatography (HPLC) methods: the formation of higher molecular weight proteins was assessed by size exclusion liquid chromatography whereas assays for related compounds and chemical potency tests were carried out using reverse-phase HPLC-UV. Conformational changes were investigated by measurements of circular dichroism.

Results: After gamma irradiation at 10 kGy, the recovery of insulin was 96.8%; higher molecular weight proteins accounted for 0.35% (relative peak area) and other related compounds (including A21 desamido insulin) represented 1.29%. No major structural changes and no volatile radiolytic compounds were detected.

Conclusion: Human insulin samples irradiated in the solid-state at 10 kGy (gamma rays) and 14 kGy (electron-beam) meet the European Pharmacopoeia requirements and can be considered as quite stable towards radiation from a chemical analysis viewpoint.

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