Flandres -Analyses laboratory provides elemental impurities analysis according to the ICH Q3D guideline for pharmaceutical products .
We can analyze the different elements with ICP -MS (plasma emission spectrometer with mass detection) with a low limit of quantification to calculate the Permitted Daily Exposures (PDE) required by the guideline.
We work regularly for pharmaceutical laboratories and use efficient analytical equipment to provide you with reliable and fast results.
You can send us your pharmaceutical sample wherever you are by using a classic shipping company.
Do not hesitate to contact us for more information.
What is the ICH Q3D directive?
The ICH Q3D directive published on December 18, 2014 regulates the control of heavy metals and elemental impurities in drugs.
- It has to be implemented by June 2016 for the new pharmaceutical products and by December 2017 for the already pharmaceutical products.
It regulates the Permitted Daily Exposures (PDE) for each element according to the process of absorption of the drug (oral , parenteral inhalation).
Proposed analytical solution :
- We propose a validation of the analytical method specific to your matrix. We can carry out the analytical validation according to the ICH Q2 “validation of analytical procedure” guideline or according to our standard protocol.
- The analysis is performed in ICP-MS (inductively coupled plasma mass spectrometry).
The determination of all the elements included in the ICH Q3D Directive is carried out with low quantification limits to comply with the directive.
The analytical results in μg /g can be converted into PDE according to the ICH Q3D guideline formula (option 1) (the other calculation options are available).
PDE(µg/day)= Concentration (µg/g) x daily amount of drug product ( g/jour)
Lists of elements and Permitted Daily Exposure PDE according to ICH Q3D guideline
|Our analytical method|
|Cadmium (Cd)||1||5||2||2||· ICP –MS according NF en ISO 17294-2
· Equipment :
7700 series ICP-MS (Agilent technologies)