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Pharmacopoeial Quality Standards for Radiopharmaceuticals for Positron-Emission Tomography

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Pharmaceutical Chemistry Journal Aims and scope

The current state of quality standards for radiopharmaceuticals (RPs) for positron-emission tomography (PET) is assessed considering primarily national and global requirements for pharmacopoeial practice. The need to develop both general pharmacopoeial standards for RPs for PET and specific monographs for separate pharmaceuticals is established. Common approaches to standardization of each quality indicator are proposed considering known features of PET RPs using dosage forms for parenteral administration as examples.

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Acknowledgments

The work was performed in the framework of a State Task for SCEEMP, Ministry of Health of Russia, No. 056-00154-19-00 for applied scientific research (State Acct. No. NIR AAAA-A18-118021590049–0).

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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051, Russia

    A. S. Gromakov, E. I. Sakanyan, S. P. Senchenko & R. D. Ruziev

Authors
  1. A. S. Gromakov
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  2. E. I. Sakanyan
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  3. S. P. Senchenko
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  4. R. D. Ruziev
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Corresponding author

Correspondence to A. S. Gromakov.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 4, pp. 61 – 64, April, 2020.

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Gromakov, A.S., Sakanyan, E.I., Senchenko, S.P. et al. Pharmacopoeial Quality Standards for Radiopharmaceuticals for Positron-Emission Tomography. Pharm Chem J 54, 419–421 (2020). https://doi.org/10.1007/s11094-020-02213-y

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  • DOI: https://doi.org/10.1007/s11094-020-02213-y

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