Stability of hydrocortisone in Polyethylene Glycol Ointment U.S.P

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1973

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The degredation of 1 per cent hydrocortisone in Polyethylene Glycol Ointnent U.S.P. was investigated. The stability tests were conducted on two different batches of ointments at three different temperatures (23[degrees], 45[degrees] and 60[degrees] C) for about four months. The decomposition was noticed in both the C=17 side chain as assayed by blue tetrazolium reaction, as well as in Ring A as determined by ultra violet spectroscopy. The decomposition was much faster on the C-17 chain (average half life was 186 days at 60[degrees]) as compared with Ring A (average half life 505 days at 60[degrees]), The order of reaction for the decomposition of the C-17 chain appeared to be first order and for Ring A zero order. The energy of activation was determined to be 9.7 kcal/mole. Based on these studies the shelf life for 1 per cent hydrocortisone ointment in polyethylene glycol base has been suggested to be about six months. The shelf life may be extended to about nine months with the addition of a 5 Per cent overage of the active ingredient at the time of manufacture.

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