Louise, regarding "Essentially Free" I would refer you to the German
Pharmacopea (DAB) which refers to a test procedure DAC-Test 5 which
provides a quantitative assessment for "Essentially Free". If may be hard
to find a copy if you don't have a German connection. So you can e-mail me
and I could send a fax.
Regarding the USP PM, I feel any FDA reviewer of a new application will
request a Visual Inspection requirement (just my experience).
Dan Hoch
Director Validation Services
danhoch@protocollink.com
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