What are the concentration limit for class-1 residual solvents in ICH ?
Answer Posted / b.gangatharan
1)Benzene(2ppm)
2)1,2-Dichloroethane(5ppm)
3)1,1-Dichloroethene(8ppm)
4)Carbon tetrachloride(4ppm)
5)1,1,1-Trichloroethene(1500ppm)
Ref:ICH Q3C Guidelines
Thanks,
B.Gangatharan,
Caplin Point,Unit-1
| Is This Answer Correct ? | 3 Yes | 2 No |
Post New Answer View All Answers
what is procedure of actual procedure for registration of drug?
why we use Dichlorobenzene.nitrobezine.t-butyldi sulhate.for calibration of gc Head space
what is definition of validation? which components are followed give detail?
why glutent are detected in the rice cereal baby food product even manufacturer claimed that they are using rice and milk only?we have using ELISA to do the test,and rice supposed not containing any glutent,rite?We already repeat the test so many times and it still detected.just wondering where the glutent came from?
How do we get end points and how many end points are possible for citric acid and di-acid not theorotically answer should be given practically.
give clarity of linearity and range in method validation
Principle of single pan analytical balance
How to establish relative response factor for hplc. Why it is required?
WHY given much noise PDA dector then VWD Dector
IS THERE ANY EQUIPMENT TO CHECK AND CALCULATE THE POLARITY OF A LIQUID?
Why irmoisture balance is used for corrugated box moisture testing
Why perchloric acid used for potentiometric titration
How to calculation of residual solvent methanol (3000 ppm) standard solution, and how many quantity used of test sample
how you determine moist.of NaOH sol or NaOH flacks
in which situation require to change rs specification?