lovastatin substance

Questions to the firm

According to remarks of the Ministry of Health, received to the draft of normative documents on lovastatin substance, following changes are to be made in the normative documents:

1.      In assay of the impurity E it is necessary to provide preparation of the reference solution at concentration equivalent to the content of impurities: 0.5%, i.e., 0.005 mg/ml. We ask the firm to provide us with method of preparation of the reference solution and chromatograms.

2.      In the "Related substances" section it is necessary to add to the system suitability test method sensitivity test (S/N). Please provide us with method of preparing solution for verification of this parameter and evaluation criterion.

      In the “Chromatographic conditions” section full trade name of the column must be     included (in the Ministry of Health, during pharmacological assessment, analysis was            performed using column Zorbax RX-C8, 250 × 4,6 mm, 5 mm).