Q3C(R4): Impurities: Guideline for Residual Solvents

Regulatory Resource: Q3C(R4): Impurities: Guideline for Residual Solvents

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

Impurities: Guideline for Residual Solvents (Maintenance)

A Maintenance process has been done to revise PDEs, as new toxicological data for solvents becomes available.

The two documents have reached Step 4 of the process in September 2002.

Limit values for two residual solvents in drug products were revised on basis of the newly recognized toxicity data; lower PDE (permissible daily exposure) for N-Methylpyrrolidone being kept in Class 2 (limited by health-basis) and for Tetrahydrofuran being placed into Class 2 from Class 3 (no health-based).

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