Harmonization of quality indicators of the domestic parent substance fentanyl
- 38 Downloads
We present a comparative analysis of the methods for quality evaluation and standardization of the parent substance of fentanyl based on foreign pharmacopoeias and domestic regulations. Harmonization of the tests and norms is proposed for the sections identification, determination of foreign impurities, and quantification. The harmonization is carried out at the stage of monograph preparation for the revised version of existing regulations.
KeywordsFentanyl Parent Substance Ammonium Carbonate Fentanyl Citrate Monobasic Potassium Phosphate
Unable to display preview. Download preview PDF.
- 1.I. K. Danusevich, Pharmacotherapy in Surgery [in Russian], Handbook, Vysheishaya Shkola, Minsk (1992), p. 352.Google Scholar
- 3.British Pharmacopoeia, BP 2005, “Fentanyl.”Google Scholar
- 4.European Pharmacopoeia, Eur. Ph. 5.0, “Fentanyl.”Google Scholar
- 5.US Pharmacopoeia, USP 29, “Fentanyl citrate.”Google Scholar
- 6.FSP 42-0131-2951-02, “Fentanyl.”Google Scholar
- 7.U. A. Murashova, N. P. Sadchikova, L. V. Skalkina, and S. K. Smirnov, Khim.-farm. Zh., 38(6), 48–50 (2004).Google Scholar