Summary
The stability of the (W.H.O.) 4th International Standard for Insulin, has been assessed by accelerated thermal degradation studies. This is a crystalline preparation of insulin, freed from proteolytic enzymes, sealed in ampoules containing air and with a moisture content of 5–6%. Of the original biological activity 95.8 (92.8–98.9; P=0.95)% was retained after storage for 12 years in the dark at 20°C and 65.7 (63.4–68.1; P=0.95)% after 14 years at 37°C. Degradation rate constants were calculated from these data for the Standard at 20°C and 37°C, assuming first order kinetics. The degradation constant at 37°C did not differ significantly from those found in earlier degradation studies at 37°C over shorter periods, thereby supporting the assumption that the degradation of crystalline insulin, at least at 37° C, is a first order reaction. Extrapolation of these data suggests that the Standard stored at −20° C for 20 years would have retained at least 99.93% (P=0.95) of its original activity and so for practical purposes can be considered to be stable.
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Starring, P.L., Greaves, P.L., Mussett, M.V. et al. Stability of the 4th International Standard for Insulin. Diabetologia 11, 581–584 (1975). https://doi.org/10.1007/BF01222110
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DOI: https://doi.org/10.1007/BF01222110