Where can I find the product-specific temperature for the loss on drying test in the USP monographs?

Quality Control
1

Hey!

I’m trying to find the specific temperature for the loss on drying test for Modafinil tablets. However, I can’t find this information in the monograph. Where is this information found?

Thanks

2

Generally in the product-specific monograph in USP, it is specified under each test the “Test method” reference number in brackets. Please refer to the test number as referred to in the test of Loss on drying in the monograph of Modafinil tablets in the USP. Please refer to this test in the general test methods in USP where the specific temperature is mentioned to perform the test of Loss on drying.
Please confirm.

3

Thank you for your response. The thing is I cannot find a “Loss on drying” test on the Modafinil tablets monograph. Also, test 731 in USP “Loss on Drying” does not mention a temperature and says it’s mentioned in the specific product monograph. No temperature is mentioned in the Modafinil Tablets monograph. Am I checking the wrong documents?

4

Hello Ahmed,

Please look at the monograph of Modafinil tablets USP. In that refer Loss on drying test, the test method number is specified in a bracket near the title of Loss on drying test.

Please refer to that test method in the USP chapter of general test methods where you will get all the details of how to carry out the Loss on drying test including specific temperature and other conditions.

You can share the USP monograph of Modafinil tablets for my reference and also the general test method chapter in USP where the LOD test in detail is given.

5

When you did not find the Loss on drying test in the USP monograph of Modafinil tablets USP then why are you looking for this test??

You will not get this test detail. You should not perform this test for Modafinil tablets USP.

Hope the matter is clear.

1 Like
6

Because we have specifications that call for the test but say that the temperature for the LOD test can be found in USP. It’s strange.

Anyway, thank you for your time.

7

Please find out who has developed the specifications of this product. Generally product development (R&D) and Regulatory dept. suggest for the specification of that product based on product development data and Regulatory requirements.
Therefore, please seek advice from those departments about this test (LOD). Also please ask R&D how did they perform the LOD test during product development and optimization of the manufacturing process? It’s very strange…!!

8

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