What is difference between hold time study and stability study?

Quality Assurance
1

what is difference between hold time study and stability study ?

2

@tshalini Both are different, we do hold time study for in-process but stability is carried out in finished product.

2 Likes
3

Which one should be used temperature probe with data logger or wire less data logger for cold storage,freezer,walkin chamber,deepfreezer,incubator mapping ,…can we used both either any difference …

4

@Harishankar As per your convenience you can used any of one (data logger with temperature probe or wire less).
If you are using data logger with temperature probe, the probe should be keep exact location where u monitored the temperature or location defined in your temp. mapping protocol.

2 Likes
5

Create new a topic for a different question.

2 Likes
6

Both are different… hold time study is done during in process stage but stability studies are performed on finished product to check how long a particular product could remain effective…

3 Likes
7

Hold time study provide you maximum time for hold the batch in inprocess or bulk stage while stability study provide you self life of product for finished product.

2 Likes
8

Hold Time study is used when products are in-process. To ensure how much time we can hold a product in quarantine in form of granules, compressed tablets, coated tablets etc.

Whereas, when we want to know how stable a product will be during its entire shelf life, we need to carry out stability studies.

2 Likes