Abstract

WOOD-DUQUE, Mayra et al. Validation of Ellman's method for determining sulfhydryl group concentrationin samples of the synthetic vaccine against Haemophilus influenzae type b. Vaccimonitor [online]. 2014, vol.23, n.2, pp. 73-80. ISSN 1025-028X.

Ellman´s method for determining sulfhydryl groups in the Haemophilusinfluenzae 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

Keywords : Haemophilus influenzae; Ellman´s method; validation.

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