Hold time study of product

Quality Assurance
1

Which strength consider for hold time study of product… Highest or lowest …plz suggest with reference…

2

The lower and higher strength

3

For same API or product?? Which one??

4

Product

5

For example … Amlodipine tablet 5 mg and 2nd is Amlodipine tablet 10 mg …which one is consider for hold time??

6

Both will be taken

7

Generally, the highest strength of the same product should be considered for the ‘Hold time’ study, provided same excipients are used in all the strengths of that product.

8

Thank you sir

9

You are always welcome…

10

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