Measuring residual solvents is mandatory for the release testing of all active chemical ingredients.
Pallavi Gupta, Ruchi Gupta, Pinaki Ranjan Samanta and Pradeep Shah, Uflex Ltd (Chemical Division), Noida, India05.11.18
A simple and sensitive method for the simultaneous determination of methanol, ethanol, iso propyl alcohol(IPA), methyl ethyl ketone (MEK), methyl isobutyl ketone (MIBK), n-propyl alcohol (n-PA), ethyl acetate (EA), n-butanol, n-propyl acetate (n-PAc), toluene and ortho-xylene by headspace techniques with FID detection is described. An efficient and sensitive method was successfully developed and validated for the determination of above mentioned solvents of varying polarity used as residual solvents from printing ink.
Based on Good Manufacturing Practices, measuring residual solvents is mandatory for the release testing of all active chemical ingredients. The method was validated for repeatability, linearity, limit of detection, limit of quantification and recovery according to the International Conference on Harmonization guidelines. The method validation results indicate that the method is accurate, precise, linear and sensitive for solvents assessed in the printing in
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