Method validation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

In Azithromycin USP the related substance & assay to be tested by Amperometric electrochemical detector but i don’t have the detector.

Can i use the BP method to test the material.

& if yes there is any guideline for the same.

Suggest some alternative method so that i can test the material.

2

If you are exporting the drug to USA, then you’d better conform to the USP (FDA-recognized standard).
I think you can adopt the BP, provided that studies have been conducted to show the equivalence of the results obtained by BP and USP. However, method validation may be needed.
Any other opinions?

3

I can’t prove the equivalency of the method due to unavailability of detector.
what alternate i can use.

4

you could use alternative validated procedures. I will give you the explanation from USP about this next monday.

5

see question #12.

6

[quote=anup_s82]In Azithromycin USP the related substance & assay to be tested by Amperometric electrochemical detector but i don’t have the detector.

Can i use the BP method to test the material.

& if yes there is any guideline for the same.

Suggest some alternative method so that i can test the material.[/quote]
Hi
i guess that you must perform complete validation for BP method and about the comparison study, it must be done.
you can perform this study for one time with any lab have this specified detector

Regards

7

thanks syx for that link

8

we use UV-detector for azithromycin.