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What are the concentration limit for class-1 residual solvents in ICH ?



What are the concentration limit for class-1 residual solvents in ICH ?..

Answer / 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

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