Introduction:

the CM-95 solution constitutes a candidate for immunomodulatory medication in the therapy of cancer patients, who must comply with Good Production Practices with the corresponding quality and stability control, according to current regulations. It was determined the stability of the CM-95 solution and the leukocyte count in Balb / c mice at the time of magnetic relaxation.

Methods:

three pilot lots were prepared, which were subjected to shelf stability and accelerated life studies. The quality indices determined before and after the magnetic treatment were: organoleptic characteristics, pH, electrical conductivity, sodium chloride titration, preservation concentration and microbiological control. Total white blood cell count in Balb / C mice was determined before and after treatment.

Results:

compliance with the parameters established in accelerated conditions and solution life, without and with magnetic treatment, was demonstrated. The utility of the container-closure system selected during the study was demonstrated. The total white blood cell count showed variations with respect to the control up to two months as an effect of the magnetic treatment.

Conclusions:

compliance with the established quality indices of the magnetically treated CM-95 solution was demonstrated, under accelerated conditions and useful life using both types of packaging. The activation of the immune response was evident from the treatment up to two months. It was found that the magnetic relaxation time of the solution was two months.

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