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

Abstract 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 %.