Organic volatile impurities in pharmaceuticals
Department of Quality Assurance, Al-Ameen College of Pharmacy, Bangalore - 560 027, India
S B Puranik Department of Quality Assurance, Al-Ameen College of Pharmacy, Bangalore - 560 027 India E-mail: [email protected]
Organic volatile impurities are residual solvents that are used in and are produced during the synthesis of drug substances, or in excipients used in the production of drug formulations. Many of these residual solvents generally cannot be completely removed by standard manufacturing processes or techniques and are left behind, preferably at low levels.