Hold time study for moisture sensitive product

Validation
1

Hi all,
during the holding time study of moisture sensitive product, is that only a part of the batch will be stored as final blend, after that as core tablet and coated tablet to be the subject of this study, and the rest of the batch will be backed, since the product is sensitive to humidity, or the whole batch will be stored as final blend at first for a period of time to study hold time, before going to compression, and the same for the core and coated tablets?
Also concerning the study time, should we follow the guidance or there are specific study time since the product is sensitive to humidity.

Thanks in advance.

2

The more realistic scenario is holding a part of blend and commencing compression after the hold time period intervals.
Better consult R&D formulation to understand the nature of product then conduct the study.

Thanks

1 Like
3

Thanks sir for the response, what about the study time for each step, are there any guideline to follow (Concerning moisture sensitive products) or we must define them ourselves during the study.

Thanks in advance

4

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