Attestation of the primary standard sample of a new analgesic agent 1-phenyl(phenylimino)methyl) pyrrolidine-2,5-dione, development and validation of a method for quantitative determination of the substance by HPLC

Trukhanova, Yulia A.; Alekseeva, G. M.; Yakovlev, I. P.; Spiridonova, Dar’ya V.

doi:10.1016/j.microc.2021.106991

Cited by 2 publications

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“…Nuclear magnetic resonance spectrometry) [2] according to the method of the internal standard, [14,15] The standard sample 1-phenyl(arilimino)methyl)pyrrolidine-2,5-dione (FFMP) (99,83 � 0,31 %). [16,17] For the test, about 50 mg (exact weight) of a standard sample was placed in a measuring flask with a capacity of 5.0 mL FFMP, about 50 mg was added (exact weight) TJ-8_215. 3.0 mL of dimethyl sulfoxide-d 6 was added, mixed until the sample was completely dissolved and the volume of the solution was brought to the mark with the same solvent, mixed.…”

Section: Methodsmentioning

confidence: 99%

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The Practice of Attestation Primary Reference Samples on the Example of a New Potential Analgesic Agent – 2‐({[4‐Nitrophenyl] imino}(phenyl)methyl)isoindoline‐1,3‐dione

et al. 2023

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Attestation of primary reference standard of a potential analgesic agent ‐ 2‐({[4‐nitrophenyl]imino}(phenyl)methyl)isoindoline‐1,3‐dione (TJ‐8_215) for the purpose of further use of this sample in the development and validation of analytical techniques, as well as for routine quality control of the substance TJ‐8_215 in extended preclinical studies. To calculate the attested value and its combined uncertainty by the mass balance method, the analysis of the substance TJ‐8_215 was carried out according to such indicators as authenticity (X‐ray, NMR, ESI‐MS, IR), related impurities (HPLC), residual organic solvents (GC), water, chlorides, metal impurities (AES). Kjeldahl titration and NMR spectroscopy were used as comparison methods to assess the quantitative content. The equivalence of the obtained results was proved and the attested value of the measured value calculated by the mass balance method was assigned, which was 99.6±0.3 %.

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Section: Methodsmentioning

confidence: 99%

“…Quantitative determination was performed in accordance with EP (2.2.33. Nuclear magnetic resonance spectrometry) [2] according to the method of the internal standard, [14,15] The standard sample 1‐phenyl(arilimino)methyl)pyrrolidine‐2,5‐dione (FFMP) (99,83±0,31 %) [16,17] …”

Section: Methodsmentioning

confidence: 99%