There are structural alerts for presence of genotoxic impurities. You can browse internet for this. If the inputs of the process has any such alert functional groups, it is necessary to evaluate and confirm the presence (or absence) of genotoxic impurities.
Please how do you interpret this information? Impurity A, B, C, D, E and any other impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 %) Total: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3%) Disregard limit: 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.0025%) Thank you
You have to interpret the information as follows The concentration of main compound selected for determining the impurities A,B,C,D and E is 0.1%. The area corresponding to that peak will be equal to 0.1%. In this case relative response factor for all the impurities is considered as one. So, any impurity (A, B, C, D, E ) area should be less than the area of 0.1% principle peak. Total impurities should not be more than 3 times the peak area of 0.1% principle peak. That means, the total should be within 0.3% Any peak area less than 0.25% (1/4th area of 0.1% peak area) should be disregarded (not to be considered in total). It is important to note that even though each impurity area is allowed up to 0.1%, total cannot be 0.1% + 0.1% + 0.1% + 0.1% + 0.1% = 0.5%. It should be not more than 0.3%. So, some of impurities A, B,C, D or E should be much less than 0.1% to account to total of not more than 0.3% in total. I hope it is clarified.
Sir, fantastic lecture. Please take lecture on isolation of impurities by PREP HPLC lecture
very helpful sir, pls if possible can u provide the ppt of this lecture
Very helpful, please provide a video showing impurity calculation.
Let me explore sooner...
How to form genotoxic impurities in API during manufacturing? What is the source sir
There are structural alerts for presence of genotoxic impurities. You can browse internet for this. If the inputs of the process has any such alert functional groups, it is necessary to evaluate and confirm the presence (or absence) of genotoxic impurities.
Please how do you interpret this information? Impurity A, B, C, D, E and any other impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 %)
Total: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3%)
Disregard limit: 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.0025%)
Thank you
You have to interpret the information as follows
The concentration of main compound selected for determining the impurities A,B,C,D and E is 0.1%.
The area corresponding to that peak will be equal to 0.1%.
In this case relative response factor for all the impurities is considered as one. So, any impurity (A, B, C, D, E ) area should be less than the area of 0.1% principle peak.
Total impurities should not be more than 3 times the peak area of 0.1% principle peak. That means, the total should be within 0.3%
Any peak area less than 0.25% (1/4th area of 0.1% peak area) should be disregarded (not to be considered in total).
It is important to note that even though each impurity area is allowed up to 0.1%, total cannot be 0.1% + 0.1% + 0.1% + 0.1% + 0.1% = 0.5%. It should be not more than 0.3%. So, some of impurities A, B,C, D or E should be much less than 0.1% to account to total of not more than 0.3% in total.
I hope it is clarified.
@@pharmaworldk1473 Very clear sir. Thank you.
You are welcome