English to Russian Science Medical: Pharmaceuticals

DOCUMENT OBJECTIVE: to elaborate a written documentation in order to prove that the endotoxins assay test method used for the product Clofarabine 20 mg/ 20 mL -concentrate for solution for infusion- is a precise and reproducible method, and that all the conditions required by the Ph. the linearity of the standard curve; the non-contamination of the test and the removal of the interference factors for the analyzed product.