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

• Published in: ChemistrySelect (Weinheim) Vol. 8; no. 1
• Main Authors: Trukhanova, Yulia A., Terninko, Inna I., Spiridonova, Dar'ya V., Generalova, Yulia E., Ermachenkov, Roman, Alekseeva, Galina M., Kuvaeva, Elena V., Yakovlev, Igor P.
• Format: Journal Article
• Language: English
• Published: 09-01-2023
• Subjects: Gas chromatography; Liquid chromatography; NMR spectroscopy; Trace analysis; X-ray diffraction
• ISSN: 2365-6549; 2365-6549
• DOI: 10.1002/slct.202204295

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 %.
Attestation of the primary standard sample of a new effective non‐opioid analgesic agent TJ‐8_215 for further pharmaceutical development. With the proven authenticity of the sample by X‐ray, NMR, ESI‐MS, IR methods, the assessment of the content of the basic substance by the mass balance method was carried out. The obtained value was confirmed by Kjeldahl titration and qNMR spectroscopy.