Interested to Buy Any Domain ? << Click Here >> for more details...
How to fix the concentration for RS by HPLC
- 10 Answers
- 48210 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
what is %labelled amount in content uniformity of dosage unit and its calculation?
effect of pore size, pore volume, partical size, column length, carbon load on retention time? what is carbon load? what is the use?
Which is the highly polar and highly non polar column in HPLC?
why cone formation during dissolution?
Why a1% value is used for some product ? What is the criteria for selection a1% value ?
What is the use of tlc and hplc? And when and where use?
how require to set assay concentration for standard and sample?
what is impurity profile. how to interpret this impurity profile to a drug product or drug substance.
In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?
how require to select dissolution media? what is discrimination?
How to set analyticl specification for combination products?
What is mean by PDR?
WHAT IS THE CRITERIA FOR SELECTION OF TIME OF DISSOLUTION AND THE MEDIUM OF DISSOLUTION?
Please tell me about the pH of Polycaboxylic ether is it in the 5-6 range ever or more than 6
What is aggregate and fragments in SEC?
