I don't have a sense of how big a deal this is, but I had a totally random thought I after I read this:
> FDA currently recognizes the high danger of this compound and lists it as a "Class 1 solvent" that "should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity ... However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted" and benzene is restricted under such guidance to 2 parts per million ("ppm").
This reminds me of a story I heard about Kosher Coca-Cola. They had designed it such that its impurities were below a certain threshold. (Googling it now, the ingredient in question was glycerin derived from non-Kosher beef tallow.) However, the consulting rabbi explained that the threshold only applied to accidental impurities; you can't put them in on purpose.
> FDA currently recognizes the high danger of this compound and lists it as a "Class 1 solvent" that "should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity ... However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted" and benzene is restricted under such guidance to 2 parts per million ("ppm").
This reminds me of a story I heard about Kosher Coca-Cola. They had designed it such that its impurities were below a certain threshold. (Googling it now, the ingredient in question was glycerin derived from non-Kosher beef tallow.) However, the consulting rabbi explained that the threshold only applied to accidental impurities; you can't put them in on purpose.