[is]
Afgangsraki Í hverri framleiðslulotu frostþurrkaðra lyfja skal kanna hvort allur raki er horfinn
[en] Residual humidity Each batch of lyophilised product shall be tested for residual humidity.
Skilgreining
[en] in a freeze-dried product, the ratio of the mass of residual water to the mass of lyophilizate (IATE)
Rit
[is]
Tilskipun framkvæmdastjórnarinnar 2009/9/EB frá 10. febrúar 2009 um breytingu á tilskipun Evrópuþingsins og ráðsins 2001/82/EB um Bandalagsreglur um dýralyf
[en] Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use