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How to fix the sample concentration in related substances development.
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Answer / 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
for more clarification contact 07709180670
| Is This Answer Correct ? | 36 Yes | 1 No |
Answer / sambhaji pawar
Depends on the linearity of the principal peak ,LOD and LOQ of all impurities,peak purity these parameters are important to fix the concentration in rel.sub.development. sambhaji pawar 8169166702
| Is This Answer Correct ? | 0 Yes | 2 No |
Answer / dr.v.gangadhar 07702224651
find out the concentration based on signal to noise ratio of the impurity which is eluted with low responce. S/N should be greater than 30 for Specification level. (0.15% or 0.10%)(Minimum three times higher than the LOQ value and 10 times higher than LOD.
| Is This Answer Correct ? | 2 Yes | 7 No |
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