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
please explian me about area normalisation method,diluted standard method,impurity vs impurity and which one has to be selected in method development
Why use only methanol,used determinationof moisture content not use other solvents
Many times I don't got a caffeine peak in calibration of hplc using guard column ❓
What is mean by PDR?
WHICH STANDARD WE USE IN SILICA ANALYSIS IN SILICA-GEL METHOD FOR SOLID SAMPLE
what is biorelivent dissolution media?
which are the diffrent batches in the pharmaceuticals?
how we can identify the impurity is coming below loq at transfering site?
process of Diclofenac sodium,IP.
what is the procedure for cleaning of lenses of hatr accesory of ftir instrument?
how require to set assay concentration for standard and sample?
How we can identify process related and degradation impurity in single method with short period?
what is mean by extactable and leachable study?
In HPLC calibration, caffeine is used as primary standard for wave length calibration due to caffeine is having dual maxima at 273 & 205 nm and one minima at 245 nm. Any body can give reference of these details from any pharmacopeia (with chapter no.) or any other authentic guideline?
how you fix the limits of impurities?