How to fix the concentration for RS by HPLC
- 10 Answers
- 43924 Views
- Intas, Reddy Labs, I also Faced
- E-Mail Answers
Answer Posted / 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 |
Post New Answer View All Answers
If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?
What is viod volume and peak purity in HPLC?
In HPLC Calibration, On which basis RSD Limit of noise test is fixed (NMT 33.0 % )
How to set analyticl specification for combination products?
what is turbidimetric titration?Give 2 examples.
Why are use silicon oil mr?
Tell me about analytical method validation in QC
What is stray light in uv what are units for stray light
why lactose has less charges when packed in steel containers when compared with packing of lactose in polyamide material?
how you start the solubility study?
How to determine water content of bis tetrazole amine mono ammonium salt
for which product require to do content uniformity? what is limit of cu?
why we are using hexane in calibration of number of drop per mL
in stress study if your api not soluble in hcl naoh h2o2 then what require to do?
What is Band broading effect explain
