Skip to main content

Advertisement

Table 5 Contributions of the different combinations of residual solvent and impurities contents on the experimental Elemental Analysis results

From: Mat-CHN software for drug substance titrations in discovery and development

Impurities and residual solvent contents combinations inserted in Mat-CHN for centesimal composition calculations Experimental Elemental Analysis results
%C: 51.720 %H: 4.708 %N: 19.054
Nb Butanol-1 (%) Des-chlorinated impurity (%) Di-chlorinated impurity (%) CHN content differences between combinations and experimental results
Δ %C Δ %H Δ %N
1     0.276 − 0.081 0.350
2 0.35    0.307 − 0.050 0.277
3   0.3   0.287 − 0.079 0.354
4    0.6 0.255 − 0.084 0.342
5 0.35 0.3   0.318 − 0.048 0.281
6 0.35   0.6 0.287 − 0.053 0.269
7   0.3 0.6 0.267 − 0.082 0.346
8 0.35 0.3 0.6 0.298 − 0.051 0.273
  1. Italic figures are out of the acceptance criteria