analyse ICH Q3D

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)

Analyse ICP (ICH Q3D)

ICP analysis (ICH Q3D)

Lists of  elements and Permitted Daily Exposure PDE according to ICH Q3D guideline

 

Elément Class Oral PDE

(µg/day)

Parenteral PDE

(µg/day)

Inhalation PDE

(µg/day )

Our analytical method
Cadmium (Cd) 1 5 2 2 ·        ICP –MS according  NF en ISO 17294-2

·        Equipment :

7700 series ICP-MS (Agilent technologies)

 

Lead (Pb) 1 5 5 5
Arsenic (As) 1 15 15 2
Mercury (Hg) 1 30 3 1
Cobalt(Co) 2A 50 5 3
Vanadium(V) 2A 100 10 1
Nickel (Ni) 2A 200 20 5
Thallium (Tl) 2B 8 8 8
Gold (Au) 2B 100 100 1
Palladium (Pd) 2B 100 10 1
Iridium (Ir) 2B 100 10 1
Osmium (Os) 2B 100 10 1
Rhodium (Rh) 2B 100 10 1
Ruthenium (Ru) 2B 100 10 1
Selenium (Se) 2B 150 80 130
Silver (Ag) 2B 150 10 7
Platinum(Pt) 2B 100 10 1
Lithium (Li) 3 550 250 25
Antimony (Sb) 3 1200 90 20
Baryum (Ba) 3 1400 700 300
Molybdenum (Mo) 3 3000 1500 10
Copper (Cu) 3 3000 300 30
Stain (Sn) 3 6000 600 60
Chromium (Cr) 3 11000 1100 3