SciX • The Great Scientific Exchange

SciX is the premier meeting for analytical chemistry and allied sciences. We’ll be at Booth #509 assisting Timegate — see Timegate’s state-of-the-art spectrometer instruments and industrial probes, including the time-resolved PicoRaman:
https://www.mccrone.com/product-category/instruments/spectroscopy/

For more about Timegate, visit https://www.timegate.com/.

McCrone Associates‘ Vice President & Director Of Industrial Services, Craig S. Schwandt, PhD, will be presenting:

Sourcing Foreign Or Extraneous Matter Using The Particle Approach

23FORENS06: Pharma Forensics
Track 6
Southern Pacific A/G
Thursday, October 12
9:30 AM – 9:50 AM (PDT)

Abstract:
“Novel Aspect:” Forensic analysis of pharmaceutical materials requires an alternate chemical paradigm.

One common objective of pharmaceutical forensic analysis is to determine the source of foreign or extraneous matter found in drug products. The first step is to identify the foreign material. Once the material is identified, the source of the material may be determined so that the production issue can be corrected. The question is how is this best done?

Conventional chemical provenance studies utilize increasingly sensitive analytical instruments to detect smaller concentrations of elements or compounds in a bulk material. The volume of material needed for analysis also continues to decrease. This ultrasensitive, bulk analysis approach is useful and benefits from analytical instrumentation advancements. However, it is ultimately limited because the key signals are diluted by the product matrix.

Selecting a different model, one that is not new but rarely practiced, is a better method. The key to the particle approach is isolation of the particulate of interest, whether they are foreign material or unexpected reaction products, from the product matrix. Isolation removes the dilution effect so that all analytical signals reflect the primary components of the particulate. This provides a clearer picture of the composition and form of the contaminant. Analysis results from isolated contaminants can be readily compared to possible source materials to determine the cause of the problem.

As an example, stainless steel wear particles are common in pharmaceutical products. Production equipment is typically constructed of common alloys such as 304 or 316 stainless steel. However, some drug products or production procedures may be incompatible with a particular alloy, causing wear or chemical degradation, and leading to contamination. With conventional analysis of the compromised drug product, there is an increase in iron content, but useful signature elements occur below detectable concentration. Particle analysis can distinguish the specific alloy producing contamination, which can help identify the source of the problem.