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209 Upon synaptic activity, vesicular zinc is released from terminals enriched with ZnT3 and diffuses across the synaptic cleft 61 to modulate multiple postsynaptic receptors, 199,210 l including the zinc-sensitive N-methyl-d-aspartate receptor (NMDAR)

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In particular, the agency frequently cited subsections (d)(1) (failure to conduct at least one test to verify the identity of each component of a drug product) and (d)(2) ( failure to validate and establish the reliability of component supplier’s test analyses appropriately), generally together