PMID: 1205027Dec 1, 1975Paper

Stability of the 4th International Standard for Insulin

Diabetologia
P L StorringD R Bangham

Abstract

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 degrees C and 65.7 (63.4--68.1;P = 0.95)% after 14 years at 37 degrees C. Degradation rate constants were calculated from these data for the Standard at 20 degrees C and 37 degrees C, assuming first order kinetics. The degradation constant at 37 degrees C did not differ significantly from those found in earlier degradation studies at 37 degrees C over shorter periods, thereby supporting the assumption that the degradation of crystalline insulin, at least at 37 degrees C, is a first order reaction. Extrapolation of these data suggest that the Standard stored at -20 degrees 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.

References

Jul 1, 1972·Diabetes·M Pingel, A Volund
Jun 1, 1960·The Journal of Pharmacy and Pharmacology·N R STEPHENSON, R G ROMANS
Jan 1, 1928·The Biochemical Journal·A Krogh, A M Hemmingsen

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Citations

Oct 16, 2002·The Journal of Biological Chemistry· SachchidanandIain D Campbell
Apr 1, 1981·The Journal of Pharmacy and Pharmacology·B V Fisher, P B Porter

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