How to fix the concentration for RS by HPLC
- 10 Answers
- 43969 Views
- Intas, Reddy Labs, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / venkat
Concentration of sample= estimated LOQ concentration (µg/mL) x 1/desired LOQ (%) x 100
| Is This Answer Correct ? | 45 Yes | 3 No |
Answer / dhilip anand
To determine the sample concentration that gives an
acceptable LOQ
(Signal to Noise ratio, S/N) in low level spike
concentrations. The sample concentration should
be low enough to maintain linearity and precision, but high
enough to achieve the desired LOQ.
For example, if the ICH reporting limit for this drug
product is 0.1%, the LOQ of the method
should be less than 0.05% (i.e., desired LOQ, in %). By
using spike sample solutions of very
diluted concentrations for the significant related
substances, estimate the concentrations that give
a S/N of about 10 for the significant related substances.
This estimated concentration is the
approximate LOQ concentration (i.e., estimated LOQ
concentration, in µg/mL).
The following equation can be used to estimate the target
sample concentration for the method:
Target sample concentration =
estimated LOQ concentration (µg/mL) x 1/desired LOQ (%) x 100
Hi this above answer probably worksout since most of the
drug's TDI(dose) will be <1g so desired LOQ % is regarded as
0.05% for reporting threshold with 0.1% and anybody suggest
what will be the desired LOQ % when reporting threshold is
0.05% i.e., if TDI is >1g as per ICH??? Can correct the
above answer if m wrong???
| Is This Answer Correct ? | 23 Yes | 1 No |
Answer / sdfgrt
Concentration of sample= estimated LOQ concentration
(µg/mL) x 1/desired LOQ (%) x 100
Any referance for this
| Is This Answer Correct ? | 11 Yes | 0 No |
Answer / rajkumar
Please any one clearly explain the with an example.
| Is This Answer Correct ? | 9 Yes | 1 No |
Answer / sanjay prajapati
It is very simple let keep the concentration which gives
LOQ value 0.05%
| Is This Answer Correct ? | 5 Yes | 0 No |
Answer / ram
The common procedure for fixing the LOQ is assuming u r specification as 100 % and we have to achieve LOQ below 50% of specification, here impurities are may be known or unknown.
for exm. known imp limit is 1.0 % then u should try to get LOQ below 0.5%, however if u try for very low level then it is well n good.
All unknown impurities will have spe of 0.1% limit and we have to do validation of unknown with active .
| Is This Answer Correct ? | 4 Yes | 1 No |
Formula=Estimation LOQ concentration (PPM)X1/Desired LOQ concentration (%)X100.
For example as per ICHQ3B our product Reporting threshold was 0.05% this is called Desired LOQ concentration.First initially we fix sample concentration as 500 ppm.This is 100%,as per this, 0.05% LOQ ppm was 0.25 ppm this is Estimated LOQ concentration.
| Is This Answer Correct ? | 1 Yes | 1 No |
why we use kbr as constant in the FTIR ?
1 why polyesterene film used for ftir calibration ? 2 why k2cr2o7 is used for control of abs in uv ? 3 why holmium oxide used for control of wavelength in uv
Why we use 100 RPM in friability test
For standardization of volumetric solutions, acceptance limit for concentration is considered as 10% of nominal concentration and %RSD as NMT 0.2% (for appropriate no. of replicates). But , if %RSD has not met, what should be further action?
why we should take dst factor for below 1%moisture samples
0 Answers Ind Swift Laboratories,
What is intact assay method development.....?
i want model written test paper for the post of analyst in IOCL(indian oil corporation ltd) any one pls help me
define polar and non polar solvent
significane of detector wavelength accrucy in calibration of hplc
how calibrate the hplc detector
2 Answers Cipla, Shraddha Analytical Services,
When recording an IR spectrum in the lab, we take no special precautions to account for the presence of oxygen, nitrogen, or argon in the air. What are the consequences of this?
What is the procedure for UV-spectrophotometer calibration?
Organic Chemistry 
