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Step 3Laboratory qualityHPLC-UV purity, mass-spec identity, endotoxin data
Some issues improve within weeks, while others require several months of structured rehabilitation
You need to know how much of the resin to actually pipet into your column (or tube if youre equilibrating in batch mode)
W., Pietilinen, K
For a new drug with no listed Orange Book patents (an unusual situation for commercial products, but possible for early licensing or niche products), NCE exclusivity is the only barrier to generic ANDA submission for the first four years
& Heath, A
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