USP Test Method Verification

Quality Control
1

Hi!
if we are using USP test method for product testing on HPLC then we have to do verification instead of validation of test method. what are the parameters which we check for verification of USP test method.

2

All Analytical test method have to validated. If you are using a non validated method (whether it is USP or BP etc.) then you need to perform Analytical method verification. Which parameters to be considered during Analytical method verification will depend on the test type (whether it is Related substance test or Assay). The guidelines for Method verification are given in USP itself. Refer USP and you will get what should be done.

Hope this is useful.

Regards

2 Likes
3

Thanks a lot for your feedback.
actually i have to do only identification and assay on HPLC by using USP method.

1 Like
4

Only Quantification need method verification. Please check USP glossary section (Index) there will be a topic on Analytical method verification guidance. You can follow the same.
Hope it is useful.

1 Like
5

Dear Mr.Tayyab,

If you are using USP Analytical method for Assay By HPLC ,Then you have to done verification of respective method and following parameter shall be perform as a verification.

1.Specificity by Interferece
2.Specificity by Retention time
3.System suitability
4.Method precision (Spiked and Unspiked)
5.Accuracy
6.Robustness
7.Solution stability
8.Intermediate precision (Ruggedness)

Any drought feel free to share.

Thanks
suhel patel

6

What about linearity and range?not needed?method precision spikes and I spiked ?didnt understand??

7

Hi…
sorry for late reply.

Please do one thing. Give me Request on linkdin. Search with suhel patel
Regards
suhel patel

1 Like