Mobile search icon
Menu
Search >>
Eurofins BioPharma Product Testing UK >> Our Services >> Elemental Impurities testing by ICP-MS

Elemental Impurities testing by ICP-MS

Contact Us

With increasing attention on bio/pharmaceutical product safety, screening for trace metal contamination is more crucial than ever. Manufacturers must comply with the ICH Q3D regulatory guidelines for elemental impurity limits, and the simplest way to achieve this is through screening for any concerning elements. Ensuring products are safe for market release involves thorough validation and risk screening, which can be complex and time-consuming.

ICP testing is inherently complex, requiring a thorough understanding of elemental interactions, stabilities, and the influence of sample matrices on the results. Since there is no universal sample preparation method, you need tailored methods for each sample matrix during validation to ensure accurate results. We customise and validate specific methods to provide peace of mind and ensure product safety before market release, helping you get your product to market and avoid recalls.

Our experts begin by determining whether the application requires validated or non-validated methods. A fully validated approach may involve multiple methods, depending on the material and metals. Key criteria include:

  • Defining the need for a general screening method vs. specific elements of interest
  • Determining whether testing supports risk assessments or quality control
  • Establishing material specification limits
  • Evaluating material solubility

Why: Client A required ICP-MS analysis to determine what was present within their sample to ensure compliance with ICH Q3D guidelines.

For Whom: This case study is designed for clients seeking elemental impurity testing in line with ICH Q3D requirements.

How: We conducted a risk assessment screening on three batches of the product, producing a semi-quantitative elemental “fingerprint” for over 50 elements. The results indicated that Lead was present, close to the permitted concentration limit set by the ICH Q3D guidelines, while no other concerning elements were detected. Since no measures could be taken to reduce lead levels, it was essential to test all future batches after manufacture to accurately quantify the lead content. A GMP validation was also completed for the product, quantifying Lead against the specified guidelines.

Outcome: Client A now has a fully validated method to test each manufactured batch of their product, ensuring Lead levels are below the required limits and the product is safe for patient consumption.

Why: Client B attempted to validate an ICP-MS method for Class 1, Class 2A, and Class 2B elemental impurities but could not obtain acceptable recovery levels for Arsenic.

For Whom: This case study is designed for clients experiencing issues with ICP-MS sample preparation problems.

How: The client method was reviewed with the Material Safety Data Sheet (MSDS). It was noted that the sample matrix had a high level of organic components, while the method's digestion steps were designed for a lower organic matrix. To resolve this, various digestion techniques, acids, and times were tested, tailored to the elements of interest. A suitable sample preparation was achieved, followed by successful validation. The method was transferred back to the client for routine use.

Outcome: Client B now has a fully validated method for their product, showing suitable recoveries for all elements of interest, including Arsenic.

Back to Our Services

If you’re interested in working with Eurofins on a Biopharma project, fill out the form below and a member of our Team will be in contact to discuss your project.

Please enter this field. Maximum character limit is 30.
Please enter this field. Maximum character limit is 30.
Please enter this field. Maximum character limit is 30.
Please enter this field. Maximum character limit is 30.
Please enter this field. Maximum character limit is 30.
Please enter this field. Enter valid Phone Number with format (Country Code-Phone Number) Phone number cannot exceed more than 20 digits.
Please enter this field. Enter a valid Email Address.
Please enter this field. Maximum allowed characters is 5000.
Allowed file size for upload is 2 MB. Allowed file types : doc,docx & pdf.
Please accept the privacy policy .

Please fill Captcha
Something went wrong. Please try again later. Invalid text in the fields.
Thank you for your enquiry