For all impurities characterization data is required ?
If Require please Explain
which type of Impurities we have to do?
If you are talking about impurities in API (active
pharmaceutical ingredient), requirement are described in
ICH guideline.
This refer to impurity with structure similar to the one of
the API coming classicaly from:
Isomers, Enantiomer, Hydrolysis (acid ou basic, and water)
Oxydation, overreaction , raw material impurities,
intermediates(N-1, N-2..), dimer, light degradation...
All impurities detected by HPLC at a level over 0.1 % have
to be identified (characterized: means structure elucidated
by NMR, Mass spectra...).
For more détails visit my website dedicated to chemical and
process development for pharmaceuticals: www.synthorga.fr
Is This Answer Correct ? | 1 Yes | 0 No |
What is deference between the working standard and reference standard?
1 Answers Gland Chemicals, Meghmani Organics,
why we use holomium oxide for UV calibration ?
In order to avoid the pyridine catalyst use in many synthesis which is harmfull to environment, which catalyst can be used....?
0 Answers Hetero, Lupin, Reddy Labs,
What is difference between anti-aromatic and non-aromatic compounds?
hi friends, dis is ramana reddy.i have been workining in bulk drugs as QC chemist.i would like 2 change d company.but our company didn't give d OFFER LETTER,APPOINTMENT LETTER,PAY SLIP.if any body has these documents along with sample RESUME,pls send 2 my mail id i.e ramanareddy.sdpl@ymail.com
I need organic mixture analysis viva questions & answers
0 Answers Practical Viva Questions,
Is benzene aromatic?
Can you provide an overview of the properties and characteristics of Protactinium and its placement in the periodic table?
What is the difference between an ion and a radical?????
How many stereoisomers of phenylpropylene oxide are there?
we shall use Dichloromethane in last stage of API.
Why we are use glass viscometer, and what is calculation manual calculation formula as per USP. How many types of viscometre in glass type viscometer.