Hello,

In general chapter 5.4 of European pharmacopoeia, is written "It is considered that amounts of these residual solvents of 50 mg per day or less (corresponding to 5000 ppm or 0.5 per cent under Option l) would be acceptable without justification. Higher amounts may also be acceptable provided they are realistic in relation to manufacturing capability and good manufacturing practice." I would like to ask , how many solvents with this limit can exist simultaneously in a sample? and if just one solvent exists and in a higher limit than 50mg/daily, is it possible this to be justified by the claim that there is no existence of other solvents, so as sum, the daily dose of this is probably lower than that of 5 (for example) solvents at limit of 50 mg?

Thank you