Современные подходы к разработке стандартных образцов для оценки качества фармацевтических субстанций

Reference substances including pharmacopoeial reference samples are widely used in evaluation of the quality of pharmaceuticals. The leading pharmacopoeias of the World include monographs that regulate requirements to the classification, attestation, and use of reference substances. The system of the standardization of pharmaceuticals in the Russian Federation, including pharmaceutical reference substances, needs the renewal of works on the evaluation and attestation of national reference substances (standards), including pharmacopoeial reference samples.