Gautam R Desiraju - Comment
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This is a Comment on the Food and Drug Administration (FDA) Notice: Draft Guidance for Industry; Availability: Regulatory Classification of Pharmaceutical Co-Crystals
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Comment
While the implications of co-crystal formation are fairly clear in the document, the final definition of co-crystal on page 4 leaves open the possibility that a solvate or a hydrate is a co-crystal. Well, solvates and hydrates are a kind of co-crystal but for regulatory purposes, it may be better to add a caveat to this definition and say that a co-crystal is a solid that is a crystalline material composed of two or more molecules in the same crystal lattice, provided one of these molecules is not water or an organic solvent.
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Comment Period Closed
Mar 1 2012, at 11:59 PM ET
ID:
FDA-2011-D-0800-0004
Tracking Number:
80f821b4
Submitter Information
Country:
India
State or Province:
Karnataka
Submitter's Representative:
G R Desiraju
Category:
Academia - E0007
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