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How to fix the sample concentration in related substances development.
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Answer Posted / santosh kumar bariki
1. find out wave length where the response of known impurity and api are similar or nearer.
2.find out the concentration where the response of impurity and api can be easily quantitated with accuracy and precise (i.e loq at that wavelength).
3.calculate test concentration such that this loq concentration should be less than 0.05% (reporting threshold).
for example if determined concentration is 1 ppm where it can be easily quantitated with precision and accurate.
than 1 is 0.05% than what should be for 100%. that is 2000 ppm is test concentration.
if all impurity has different response consider impurity which have low response
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