Metals Testing in Pharmaceuticals
With increasing attention directed toward bio / pharma-ceutical product safety, the importance of screening for trace metal contamination is becoming more important. Eurofins BPT competence center in Denmark offers an array of testing services for a verity of applications that contribute to the product integrity, including drug substance and raw materials assay, media screening, extractable/leachable studies and final product assay.
ICH Q3D and the new USP <233> is an example of specific regulatory changes forcing the use of ICP MS and ICP AES in a GMP setting.
To detect even minor differences in metal levels for specific samples Eurofins BPT offers to detect down to ppt level, due to the extensive possibilities for sample pre-treatment in microwaves and other sample preparation techniques as well as the specially designed high pressure room to safeguard samples from contaminating air particles
Metal Competence Center services in Europe
Eurofins BPT offers the complete range of metal testing services for the pharmaceutical industry including
- Method development and validation
- Routine testing of final preparations, API, excipients and raw materials
- Advice regarding analytical methods and approaches
- Testing according to European, US,
British and Japanese pharmacopeia
Eurofins BPT operate according to cGMP and is approved by the Danish Health Authorities and registered with FDA.
Eurofins BPT provides a number of approaches to meet the specific client requirements, including the following;
- ICP-MS/AES Screening
- ICP-MS/AES Verified screening
- ICP-MS/AES Limit test
- ICP-MS/AES Self-Validating test
- ICP-MS/AES Quantitative test
Eurofins BPT can help determine the instrumentation and sample preparation that best meets testing needs and provide general instrument performance advice. For example, sensitivity limits are dependent on choice of instrumentation, sample digestion approach and available sample mass.
Why choose Eurofins BioPharma Product Testing
- Eurofins BPT has more than 35 years of experience developing and executing method for trace metals analysis, using modern quantitative technology for pharmaceuticals
- Eurofins BPT specialists have the expertise to troubleshoot complex sample matrices and method challenges.
- Eurofins BPT’s regulatory experience enables our analysts to ask the right questions and determine the most appropriate testing approach, delivering service that meets client needs
- Comprehensive instrument capacity allows for rapid turnaround time
- It is very expensive to maintain analytical competence in-house as it requires continued investment in expensive instrumentation, experts, regulatory approvals and software.
- Eurofins BPT has metal competence centers in Copenhagen, Denmark, Europe and Lancaster, PA, USA, to facilitate back-up possibilities and easy access to identical testing in Europe and USA. Both centers are equipped with identical instrumentation and work closely together in the optimization of methods and procedures. Eurofins has extensive experience analyzing elemental impurities according to ICH Q3D, USP < 233 > EP 5.20 and has completed major verified screening programs for pharmaceutical clients.
Eurofins BPT is proud to offer our clients a high level and very well documented quality service to international standards.
All equipment is installed with 21 CFR Part 11 com-pliant software and is qualified according to US and European quality requirements.
Eurofins BPT DK is regularly audited by FDA and European health authorities.