Summary. The stability of the (W.H.O.) 4th InternationalStandard 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~ did not differ significantly from those found in earlier degradation studies at 37~ 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~ 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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