Thanks, Brian.
Actually, it is USP that requires of this residual solvent testing. I
am just not sure about FDA's stance on testing all drug products
regardless of processing a drug product with and without use of
solvents. I know I may do away without testing it.
By the way, since this is an injection product, do you know if I must
submit a Microbiology copy in my ANDA with a white folder besides the
red-colored folder for the Chemistry copy?
Ed
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