González CVL, Sierra PRC, Marrero DD, Rodríguez LEA

Language: Spanish
References: 11
Page:
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ABSTRACT

Introduction: an accurate dosage the substances to be evaluated should be guaranteed in the toxicological studies. This is particularly difficult with waxy lipophilic substances, such as D-002 (fatty alcohols purified from beeswax) and D-003 (fatty acids purified from sugar cane wax). These substances require to be prepared as aqueous suspensions in order to be administered to animals used in the acute, chronic, and carcinogenic toxicological studies.
Objetive: to develop an analytical method for quality control of the aqueous suspensions used in the toxicological studies of the substances D-002 and D-003.
Methods: target suspensions were standardized at the same concentration, from these last suspensions an aliquot was taken for extracting the fatty alcohols and acids of D-002 and D-003, respectively. Internal standard solutions, which organic solvents had affinity for the active substances of interest were used. After that, aliquots of the organic phases were submitted to the formation of trimethylsilyl or methyl esters derivatives (alcohols or acids, respectively) and were analyzed by gas chromatography.
Results: the analytical method met the validation criteria, according to the international ICH guidelines, allowing the quality control of D-002 and D-003 solutions.
Conclusions: the developed and validated gas chromatography analytical method can be used for quality control of the D-002 and D-003 aqueous solutions used in toxicological studies.

REFERENCES

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