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What regulatory guidelines apply to (6R,7R)-7-{[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-3-(5,6,7,8-tetrahydro-1-quinoliniumylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sulfate (1:1) (CAS: 118443-89-3)?
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