Limit for Diethylamine

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Dear All,

Please provide the limit for Diethylamine as per ICH guidelines.

2

It is not addressed in ICH.

3

do you mean ‘diethylene glycol’ in glycerin?

4

Dear Mr.Rao,

Diethylamine is a secondary amine as per international chemical safety cards & its imediately dangerous to life or health concentration value is 200ppm.

So, based on the above, you can set the std limit less than 200 ppm.

5

Dear Sir,

I want know following information. Kindly supply following information pl…

  1. how can we fix the Residual Solvents limits for which are not present in ICH guidelines?
  2. Is there any formula or calculations? If yes please provide me.
  3. Is it required for quantification of Class-3 solvents?
  4. can we use LOD test for quantification of class-3 solvents?

Looking anxiously for your earliest reply…

Thanks in advance

Pulla Reddy Karnati
09912054829