Arpit sharma

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Residual solvent ppt

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“Residual solvents in pharmaceutical are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or Excipients, or in the preparation of drug products”. : 

“Residual solvents in pharmaceutical are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or Excipients , or in the preparation of drug products”. What is Residual Solvent :

Why Residual Solvent needed : : 

Why Residual Solvent needed : Residual Solvent needed To make Safety of the patient ; recommends use of less toxic solvents. Testing is to be performed only for solvents “likely to be present”. Used or produced in the final manufacturing step. Used in previous step and not removed by validated procedure.

Residual Solvent Classes :  : 

Residual Solvent Classes : Residual Solvent Classes As per <467> Their are three classes of Residual solvent based on the toxicity: Class – 1 Solvent – Solvents to be avoided because it is carcinogens and environmental hazrds

Residual Solvent Classes :  : 

Residual Solvent Classes :