Transcription of 2.9.19. PARTICULATE CONTAMINATION: SUB-VISIBLE …
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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) 100d2= from stage 3, m3c2=c3+m3F2=(c2/c) 100d1= from stage 2, m2c1=c2+m2F1=(c1/c) 100mass from stage 1, m1c=c1+m110001/2008 PARTICULATECONTAMINATION: SUB-VISIBLEPARTICLESP articulate contamination of injections and infusionsconsists of extraneous, mobile undissolved particles , otherthan gas bubbles, unintentionally present in the the determination of PARTICULATE contamination2procedures,Method1(LightOb scuration Particle CountTest) and Method 2 (Microscopic Particle Count Test),are specified hereinafter.
2.9.19. Particulate contamination: sub-visible particles EUROPEAN PHARMACOPOEIA 6.0 Table 2.9.18.-9. – 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 table Cut-off diameter (µm) x Mass of active substance
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