What are the class-1 residual solvents listed in ICH guidelines?
Answer Posted / b.gangatharan
According to Q3c in ICH guidelines and USP Chapter <467> the following 4 solvents are listed .
1)Benzene
2)1,2-Dichloro ethane
3)1,1-Dichloroethene
4)1,1,1-Trichloroethane
Thanks,
B.Gangatharan
Caplin point Ltd,unit-1
| Is This Answer Correct ? | 4 Yes | 3 No |
Post New Answer View All Answers
in each media we require to use SLS? how to proceed?
in api coa contains only process impurities and in product coa contains degradation impurities?
what parameters we will consider while developing a HPLC method and how we confirm our HPLC method is valid?
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
which batch require to use for analytical method validation?
In performance Check of GC Why Hexadecane Peak is ConsideredÂ
in dissolution why pool sample needed? in which type of drug pool sample need?
If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?
if you have given a blank water how you analyse by general analytical techniques?
Why to use propyl paraben in HPLC gradient calibration
How to set specification of assay, fisdolution and related substances?
if identification threshold crosses the limits then what next step?
how decide the clining method and cleaning method validation require for this perticular products?
What is the principle of Thermal conductivity detector and FID?
What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?