Assay for medical devices

[MestizoJoe]

Hi,

I'm working on an assay for a medical device. The active ingredient is a polymer that is analyzed by HPLC.

I'm wondering what type of parameters need to be tested for validation.

Since it is a polymer, I can't do Peak purity; the peak of the active elutes over a broad range of mobile phase composition (gradient) and because of this the background spectra are different and the peak purity will not pass. Even if background spectra were not a problem it would probably still fail since each species of polymer may have different spectra (different ratios for two lambda max in each polymer species).

[prepcolumn]

Even if background spectra were not a problem it would probably still fail since each species of polymer may have different spectra (different ratios for two lambda max in each polymer species).

MestizoJoe
If your polymer may have have different spectra how can you quantitate it properly?

[Johnny Rod]

According to ICH Q2 you need to validate:

Accuracy
Precision
Specificity
Linearity and
Range

You can download it for nothing from ICH. The ICh is a joint international body made up of countries including the US.

[AlexVogt]

Great you are working it own! However, such testing services are also provided by many companies, having group of experts to guarantee safe and effective performance of different medical devices. Since there are great innovation going on in medical device technology as you can see here at ilexmedical.com it’s important to evaluate the security of all products. Companies usually work with standard test techniques and generally develop specific testing ways to fulfill specific needs.