E-DRUG: Stability of oxytocin preparation - Stabilizing Effect of Chlorobutanol
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Dear e-druggers,
The different storage declarations of oxytocin products and their
stability have been a topic of discussion in this forum several times.
It might be of interest to you, that our paper 'Stability of Oxytocin
Preparations in Malawi and Rwanda: Stabilizing Effect of Chlorobutanol'
has just been published online in the American Journal of Tropical
Medicine and Hygiene:
Abstract:
Oxytocin is used for the prevention and treatment of postpartum
haemorrhage, the leading cause of maternal mortality in low- and middle-income countries. Because of the high instability of oxytocin, most products are labeled for storage at 2-8 deg C. Some other products are on the market which are labeled for non-refrigerated storage, but independent evaluations of their stability hardly exist. In the present study, seven brands (nine batches) of oxytocin were purchased from wholesalers and medical stores in Malawi and Rwanda and investigated by accelerated stability testing according to the ICH/WHO guidelines. Two oxytocin brands approved by a stringent regulatory authority (SRA) or by the WHO Prequalification of Medicines program and purchased in Europe were used as comparison. All investigated brands which were either produced in countries with SRAs, or were WHO-prequalified products, were labeled for storage at 2 - 8 deg C, and all of them passed stability testing with very good results. Even
exposure to 25 deg C or 30 deg C for several months hardly affected their oxytocin content. However, two other investigated brands were labeled for non-refrigerated storage, and both of them had been produced in countries without SRAs. These two preparations showed not higher but lower stability
than the brands labeled for storage at 2 - 8 deg C, and, for both of them,
noncompliance with pharmacopoeial specifications was found after accelerated stability testing. At 40 deg C, and in forced degradation studies at 80 deg C, chlorobutanol showed a remarkable stabilizing effect on oxytocin, which may deserve further investigation. The results of the present study
support the policy - 'Buy Quality Oxytocin, Keep It Cool'.
You are welcome to share this paper with persons and organizations who
may be interested!
Kind regards,
Nhomsai Hagen
Nhomsai Hagen
Apothekerin, Doktorandin
Eberhard Karls Universität Tuebingen
Email: nhomsai.hagen(at)uni-tuebingen.de