Elemental Impurities

Method development, validation and routine testing for elemental impurities in raw materials, excipients, APIs and finished products.

Instrumental testing for elemental impurities is a new and more specific way of testing for potentially toxic elements in pharmaceutical products. The latest requirements from the pharmaceutical authorities, means that new, specific and sensitive instrument technology implementation is vital. As a result, raw material vendors and pharmaceutical companies need to be prepared for the more stringent requirements.

SGS provides full development, validation and test methods with the cGMP documentation to support all of our testing. With our expert personnel and well equipped, state-of-the-art laboratories, we can help you meet the requirements with ease.

Why choose elemental impurities testing from SGS?

We can help to:

Guide you through the entire process, from identifying what elements to test to determining limits
Determine if you need quantitative or qualitative testing
Identify whether you should test your API or finished drug products
Understand and manage the challenges from EP, USP and ICH Q3D
Define the required impurities to test for
Define the required limits to test for
Screen for elemental impurities in a customized approach (full validated or a risk-based approach)
Set up a solid risk assessment wherever additional data is missing

We can also assist if you are combining your drug products and need your specifications to be over a range for addition type testing.

A World-leading Provider of Elemental Impurity Testing

As a world leader in analytical chemistry services, we provide the professional expertise and regulatory qualifications to perform method development, method validation and routine testing for all of your elemental impurities needs. We offer extensive experience with all the compendia proposed methodology and are ready to implement this new testing. Our highly qualified staff is always up to date on the constantly changing requirements.

We provide:

Multiple locations across Europe, Asia and North America
Multiple instruments, including ICP-OES, ICP-MS, flame/graphite AAS, hydride generator AAS
Closed vessel microwave digestion
HF capabilities
Experience with overcoming interferences (physical, chemical, spectral, isobaric, polyatomic)
Long-time experience in method development and validation
Verification of Pharmacopea methods
Experience with a huge variety of different sample types and complex sample matrices

Contact SGS today to find out how our elemental impurities expertise can help you meet the requirements set forth by regulatory agencies.