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The article illustrates the prospects of using nuclear magnetic resonance spectroscopy for complex, fast and reliable determination of key quality attributes of drug substances while performing pharmacopoeial analysis.

<jats:p> The use of assay methods with different test conditions for determination of anthracene derivatives in herbal substances and herbal medicinal products requires adjustment of the established limits for total anthracene derivatives content based on the test metho...

The article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of...

The article describes the main stages of introduction of the Good Distribution Practice (GDP) in Russia following the adoption of new laws making it mandatory for wholesalers to comply with requirements for storage and transportation of medicinal products. The article c...

«Pyrogenicity» and «Abnormal Toxicity» are considered to be among most problematic pharmacopoeia monographs in the current editions of the leading world pharmacopoeias, the reasonability of which is not obvious to all experts. The authors analyze the reasons for the int...

Russian requirements for main products derived from human plasma used to be laid out in several nonintegrated monographs that have been recently included into the State Pharmacopoeia of the Russian Federation, XIII edition. The present article compares requirements for ...