Question { Jubilant, 48712 }

what is the difference between Tailing Factor & Asymmetry

Answer

asymmetry factor=1
If asymmetry factor greater than one then that peak is Tailing
If asymmetry factor less than one then that peak is fronting

Question { 28354 }

what is the need of calulation of RRF of impurity in HPLC
analysis?

Answer

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.

Question { Micro Labs, 21100 }

What are the limits for uniformity dosage content for tablets and capsules

Answer

for 10 units (L1) A.V not more than 15
fro 30 units (L2) A.V not morw than 25

Question { Mylan, 5287 }

How you collect dissolution media while in stirring condition
of a basket or a paddle?

Answer

The USP clearly states for dissolution sampling, the sample should be withdrawn from a zone midway between the surface of the dissolution medium and the top of the rotating paddle or basket and not less than 1cm from the wall.

Question { 6436 }

What is the effect of halogen on reactivity of benzene ring and what is the reason for decreasing reactivity?

Answer

The order of reactivity among Halogens from the more reactive (least deactivating substituent) to the least reactive (most deactivating substituent) halogen is:
F> Cl > Br > I
The order of reactivity of the benzene rings toward the electrophilic substitution when it is substituted with a halogen groups, follows the order of electronegativity. The ring that is substituted with the most electronegative halogen is the most reactive ring ( less deactivating substituent ) and the ring that is substituted with the least electronegatvie halogen is the least reactive ring ( more deactivating substituent ), when we compare rings with halogen substituents. Also the size of the halogen effects the reactivity of the benzene ring that the halogen is attached to. As the size of the halogen increase, the reactivity of the ring decreases.

Question { Aurobindo, 29725 }

in hplc calibration we are using 0.05% acetone why we are
using that one and what happen when its conc increases or
decreases

Answer

acetone gives maximum absorbance at 260nm

Question { 13046 }

what is the relation of normality & molarity ? give me
formula?

Answer

Normality= 2*molarity

Question { 5338 }

why water content test performed

Answer

Are the stability results out-of-trend without an obvious root cause? Maybe the decrease in assay can be explained by an increase in water content. Non-solid product or raw material can be released without testing the water content. The amount of water is needed to calculate the purity ‘as is’ of a product and to evaluate compliance with the specification set