Copovidone Impurity – C

Ethenyl acetate (vinyl acetate). ◊FUNCTIONALITY-RELATED CHARACTERISTICS This section provides information on characteristics that are recognised as being relevant control parameters for one or more functions of the substance when used as an excipient (see chapter 5.15). Some of the characteristics described in the Functionality-related characteristics section may also be present in the mandatory part of the monograph since they also represent mandatory quality criteria. In such cases, a cross-reference to the tests described in the mandatory part is included in the Functionality-related characteristics section. Control of the characteristics can contribute to the quality of a medicinal product by improving the consistency of the manufacturing process and the performance of the medicinal product during use. Where control methods are cited, they are recognised as being suitable for the purpose, but other methods can also be used. Wherever results for a particular characteristic are reported, the control method must be indicated. The following characteristics may be relevant for copovidone used as binder in tablets and granules. Viscosity (2.2.9): determine the dynamic viscosity using a capillary viscometer on a 10 per cent solution (dried substance) or on a 20 per cent solution (dried substance) at 25 °C. It is typically about 8 mPa·s or about 23 mPa·s, respectively. Particle-size distribution (2.9.31 or 2.9.38). Bulk and tapped density (2.9.34). The following characteristic may be relevant for copovidone used as film former in coated dosage forms and in aerosols. Viscosity (2.2.9): see above.◊