For intermediate product, its necessity to include for residual solvent by GC test in specifications.
If, rs by test not in specifications, if customer asking residual solvent declaration with limit. How can we handle this pl suggest.
In general no need to test the intermediates for residual solventsā¦
Testing of API substance is sufficient by testing the residuals of all the solvents, which have been used during the manufacturing from the initial stage to API.
Every solvent to be included in the API residual solvents test and their limits as per ICH.
If the customer needs the intermediate stage with R.S test, test method to be developed and prepare separate specification for that particular customerā¦
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Thank you , Iām clear.