ELEMENTAL IMPURITIES BY ICP/MS
Missed the deadline? We have you covered!
IAL has been performing elemental impurities testing with ICP/MS utilizing microwave digestion equipment for almost 10 years. We provide method verification and product testing in accordance with USP <232><233> and ICH Q3D requirements. Let our experts show you the best way to submit your data as part of your annual product report. Call 973-361-4352 for full details.
What about my products already in development?
IAL can provide method verification and product testing for your NDA and aNDA products. Call 973-361-4352 to discuss timing of final formulations and manufacturing of registration batches.
We made the deadline ... but my product didn't meet the specifications. Now what?
IAL can provide support to quickly identify the source of the heavy metals contamination. This includes testing of APIs, inactive ingredients and in-process manufacturing samples. Call 973-361-4352 for full details on how our analytical approach will get you back to spec sooner.
My initial product testing is complete ... what's next?
The FDA has not defined requirements for future monitoring. IAL can assist in designing and performing risk assessments for your product lines and products in development. Based on the risk assessment for your product, IAL will work with you to establish a protocol for annual product evaluation, periodic product testing, raw material testing, etc., to help assure that your products stay compliant. Call 973-361-4352 for full details.
Elemental Impurities 2018
There’s more to know about ICP/MS than just the January 1st deadline. IAL has the experience to guide you through the ENTIRE process of the new USP requirements and subsequent monitoring - whether your products are on schedule, have fallen behind, or have failed compliance testing.
Be confident your products are on track in 2018 and beyond.
Call 973-361-4352 or register below for a confidential session with IAL's Laboratory Director, David Browning. During your session, Mr. Browning will personally review the FDA's expectations for your specific elemental impurities situation - and reveal the most effective and efficient next steps for your compliance strategy.