Interested to Buy Any Domain ? << Click Here >> for more details...
what is the need of calulation of RRF of impurity in HPLC
analysis?
- 9 Answers
- 31860 Views
- I also Faced
- E-Mail Answers
Answer Posted / ichinnakamisetti
Relative Response Factor (RRF) is an analytical parameter used in chromatographic procedures to control
impurities/degradants in drug substance and drug product. RRF is used to correct the difference in
detector response of impurities with analyte peak. RRF is established by slope method with linear range
of solutions. Different Pharmacopoeias refer the term RRF differently.
As per United States Pharmacopoeia (USP) The Relative response factor, is the ratio of the responses of
equal amounts of the Impurities and the drug substance1
. USP refers RRF as Correction factor or
Response factor or Relative response factor.
As per European Pharmacopoeia (Ph.Eur) The Relative detector response factor, commonly referred as
Response Factor, expresses the sensitivity of a detector for a given substance relative to a standard
substance. The correction factor is reciprocal of the response factor2
. Ph.Eur refers RRF as Correction
factor or Response factor.
As per British Pharmacopoeia (BP) The Response Factor is a relative term, being the response of equal
weights of one substance relative to that of another in the conditions described in the test3
. BP refers RRF
as Response factor.
Establishment of RRF is required to avoid the stability issues with standards, to reduce the cost
on preparation of Impurity Standards, to reduce Maintenance of Impurity Standards, due to the lack of
donation of Impurity Standards, difficulty in synthesis and isolation of Impurity Standards, for
convenience and time saving. Relative Response factor (RRF) is used in different stages: Phase 1 to
Phase 4 studies, in drug purity tests, Mass balance tests, in limit tests, In stability indicating methods etc.
| Is This Answer Correct ? | 5 Yes | 1 No |
Post New Answer View All Answers
What is a difference between potency and purity?
Why do we use KMnO4 in the test of control of obsorbance ? and why do we take specific quantity i.e 57-63mg?
is it necessary to do HPLC calibration at wavelength 315nm if we are doing analysis at this wavelangth
How doing qbd practically?
what is biorelivent dissolution media?
from where i get mortar pastle for glass bottle crush? it's required for testing of it?
Why we use potassium dichromate in uv calibration Exact reason behind it??
what is mean by 40 in the dissolution basket mesh size?
if you given one product then which tests you will perform?
how can give the expiry period and restadardisation of volumetric solution
What is mean by PDR?
what is definition of validation? which components are followed give detail?
How we choose the mobile phase for method development.?
What are modes of quantification in related substances
calibrtion procedue of LC-MS
