Wood-Duque M, Hernández-Caso N, Delgado-Martínez I, Montañez-Valdez M, Sánchez-García JC

Language: Spanish
References: 16
Page: 73-80
PDF size: 163.48 Kb.

ABSTRACT

Ellman´s method for determining sulfhydryl groups in the Haemophilus influenzae type b vaccine was validated. The following parameters were evaluated: linearity and working range, specificity, accuracy and precision. The method has proven to be linear in the range from 4 to 0.25 mM/L, it also demonstrated to be specific with accuracy from 95 to 105%. Repeatability and intermediate precision showed coefficients of variation of less than 5% and 10% respectively, below the acceptance criteria required for these parameters. L-cysteine hydrochloride monohydrate reagent was established as a positive control. Taking into account its precision, specificity and accuracy; this method becomes a necessary tool for carrying out process control in order to obtain this vaccine.

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