In December 2014, the final version of ICH Q3D was ratified by the ICH steering committee leaving manufacturers of drug products three years to comply with the new regulations.

Less than a month later, USP announced that the corresponding chapters <232> and <233> will become applicable as of January 1, 2018. 

While both guidelines are applicable for finished drug products, ICH Q3D also states that producers of API’s (active pharmaceutical ingredients) are required to test their products for elemental impurities.

ICH Q3D lists 24 elements while USP <232> includes15 elements to be evaluated against the established PDE (permissible daily exposure) limits. Elemental impurities are to be tested by ICP (ICP-AES or ICP-MS). High resolution or sector-field ICP-MS has been the instrumentat of choice at ALS Scandinavia since the mid 90’s and today our laboratory houses 11 ICP-SFMS units.

How can ALS be of assistance?

ALS Scandinavia has decades of experience working with the pharmaceutical industry and has validated more than 100 client specific methods. Our unique instrument park housing a total of 15 ICP instruments park provides us with both a solid backup capacity and the possibility to process a large number of GMP tests every day. Furthermore, we have long experience in the field of validating analytical methods for metals in drug products and no task is too challenging.

Please contact us for more information about our capabilities, to request a quote or to learn more about the new regulations and analyses of elemental impurities.

Client service
e-mail:               info.lu@alsglobal.com
Phone:               +46 920 28 9900

Sales Team Manager, Robert Omberg

e-mail:               robert.omberg@alsglobal.com
Phone:               +46 920 28 9988