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Eudralex Volume 3 Annexes to: CPMP/ICH/283/95 Impurities: Guideline for Residual Solvents & CVMP/VICH/502/99 Guideline on Impurities: Residual Solvents; ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES; ANNEX II: RESI
EMA
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Document Type:
Guideline
Content:
These two Annexes specify class 1 and class 2 residual solvents and provide guidance for the use of organic solvents in the manufacture of medicinal products.