Interested to Buy Any Domain ? << Click Here >> for more details...
How to fix the sample concentration in related substances development.
- 3 Answers
- 16834 Views
- Novartis, Watson Pharmaceuticals, I also Faced
- E-Mail Answers
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
for more clarification contact 07709180670
| Is This Answer Correct ? | 36 Yes | 1 No |
Post New Answer View All Answers
What are the primary considerations in extractables and Leachables ?
Did anybody have method for acetyl cysteine effervescnce tablet
What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?
How doing qbd practically?
What is the difference between spectro meter and spectro photo meter?
In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?
What is rs test why we are performing rs test?
If we do accuracy at same concentration at which linearity planned,what is the need to do linearity separately?
Why perchloric acid used for potentiometric titration
If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?
why glutent are detected in the rice cereal baby food product even manufacturer claimed that they are using rice and milk only?we have using ELISA to do the test,and rice supposed not containing any glutent,rite?We already repeat the test so many times and it still detected.just wondering where the glutent came from?
If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?
I have compare C2H2-air and C2H2-N2O flame AAS on determination calcium. Both use same range of std to plot calibration curve. (2-6ppm) When i measure the sample with phosphate, KCl and LaCl, C2H2-N2O flame give false positive result, around 0.5ppm. When i measure the sample with phosphste, KCl and EDTA. C2H2-N2O flame also give 0.5ppm false positive. But both above mentioned sample would not give false positive when measured by C2H2-air flame. What is the reason?
Why a1% value is used for some product ? What is the criteria for selection a1% value ?
what is different when impergnated silica plates are used in separation of azo dyes using column chromatography?
