What is the most important parameter for extended release or delayed release products for which the USP standard requires testing?

The most important parameter for extended release or delayed release products for which the USP (United States Pharmacopeia) standard requires testing is the dissolution profile.

Here are the steps to understand why:

1. Extended release or delayed release products are designed to release the active pharmaceutical ingredient (API) over a prolonged period of time. This is to maintain a constant drug concentration in the body, thereby improving the efficacy of the drug and reducing side effects.

2. To ensure that these products are releasing the API as intended, it is crucial to test their dissolution profile. The dissolution profile refers to the rate and extent to which the API is dissolved from the dosage form and becomes available for absorption in the body.

3. The USP has set standards for dissolution testing to ensure that the products are safe and effective. These standards specify the conditions under which the test should be conducted, including the type of dissolution apparatus to be used, the rotation speed, the dissolution medium, and the duration of the test.

4. If a product does not meet the USP standards for dissolution, it may not release the API at the correct rate or to the correct extent, which could affect its therapeutic effect.

5. Therefore, the dissolution profile is the most important parameter for extended release or delayed release products for which the USP standard requires testing.