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2.9.19. PARTICULATE CONTAMINATION: SUB-VISIBLE …

PARTICULATE contamination : SUB-VISIBLE particlesEUROPEAN PHARMACOPOEIA Calculations for Apparatus E. Use q = (60/Q)x, where Q is the test flow rate in litres per minute,and x is listed in the tableCut-off diameter( m)xMass of active substancedeposited per dischargeCumulative mass of active substancedeposited per dischargeCumulative fraction of activesubstance (per cent)d7= from MOC or terminalfilter, m8c7=m8F7=(c7/c) 100d6= from stage 7, m7c6=c7+m7F6=(c6/c) 100d5= from stage 6, m6c5=c6+m6F5=(c5/c) 100d4= from stage 5, m5c4=c5+m5F4=(c4/c) 100d3= from stage 4, m4c3=c4+m4F3=(c3/c)

2.9.20. Particulate contamination: visible particles EUROPEAN PHARMACOPOEIA 6.0 Wet the inside of the filter holder fitted with the membrane filter with several millilitres ofparticle-free water R.Transfer to the filtration funnel the total volume of a solution pool or of a single unit, and apply vacuum. If needed, add stepwise

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