solubility (e.g., tablet residue, Рneed for liquids) can influence the acceptability of the product being labeled as an ODT. Р Р IV. DISINTEGRATION TESTING Р Р Part of the process of determining if a product is an ODT involves testing a product to see how Р long it takes to disintegrate. Determination of disintegration time appears to be method Р dependent. Some methods are more discriminating than others. To provide both a standard for Р and consistency in disintegration testing, we mend that applicants use the USP method for Р disintegration testing.3 However, other methods that can be correlated with or are demonstrated Рto provide results equivalent to the USP method also can be used and submitted to determine Рdisintegration time. Р Р 3 USP 29, <701> Disintegration, pp. 2670-2672. Р 3
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