Identify contaminants, unknowns, and suspected counterfeit products in finished and raw materials
Comprehensive Chemical Analysis Programs
In today’s complex supply chains, unexpected impurities and unidentified compounds can compromise product safety, efficacy, and regulatory compliance. Whether arising from degradation, cross-contamination, or deliberate adulteration, unknown substances pose serious risks to patient health and brand integrity.
Robust analytical screening is essential not only to detect and quantify known contaminants—such as degradation products, leachables, and by-products—but also to flag truly unknown peaks that may represent novel impurities or counterfeit ingredients. Visual inspection and basic assays alone cannot uncover trace-level or structurally unexpected contaminants.
At Triclinic Labs, we combine orthogonal techniques—high-resolution mass spectrometry, advanced chromatography, FTIR, Raman spectroscopy, and specialized hyphenated methods—to:
- Detect and quantify known contaminants (residual solvents, metal ions, process impurities)
- Flag and elucidate unknown compounds through accurate-mass databases and de novo interpretation
- Screen for suspected counterfeit or adulterated materials by comparing spectral and chromatographic profiles against authenticated reference libraries
Our spectral libraries and chemometric models enable rapid matching of unknowns to thousands of reference spectra, while our experts develop tailored workflows to isolate and identify novel impurities. This dual focus on contaminants and unknowns ensures that even sophisticated counterfeiters—or unforeseen degradation pathways—cannot escape detection.
Why Triclinic Labs?
- Depth of Expertise: Decades of experience in pharmaceutical, bench-scale, and medical-device analysis.
- Advanced Instrumentation: Access to industry-leading MS, NMR, and vibrational spectroscopy platforms.
- Custom Method Development: Analytical protocols optimized for sensitivity, specificity, and throughput.
- Regulatory Support: Comprehensive reporting suited for FDA, EMA, and global health authority submissions.
Protect your products, safeguard patient health, and preserve your reputation by partnering with Triclinic Labs. Reach out to learn how our contaminant and unknown-screening programs can be integrated into your quality control and release testing workflows.
Contaminant, and Foreign Material Identification
If you have an unknown substance we can quickly and confidently help identify the material. We specialize in pharmaceutical and fine chemical contaminant analysis and foreign material identification.
We have expertise in analysis of:
- Failures
- OOS
- Contaminants
Pharmaceutical contamination testing and identification projects at Triclinic Labs involve off-color investigations as well as foreign materials in a product. Sources of contaminants include the environment, improper storage of the product, poor quality raw materials, items introduced during manufacturing including those from an undetected change in the process (e.g. polymorphic conversion), and unexpected sources. We work quickly and closely with you to determine the source of contamination and develop a corrective action program.
Figure 1. Analysis of a contaminant found in raw material. Optical microscopy and subsequent spectral analysis confirms the material is cotton fiber. False color SEM. For more information on microscopy and imaging please click here.
Counterfeit Analysis Capabilities - Patient Complaint Analysis Specialists
- Gross Analysis (Color, Placement)
- Paper
- Ink
- Spacial Authenticity
- Adhesive
- Container Dimensional Size and Accuracy
- Polymer Identification and Composition
- Induction Seal Integrity
- Adhesives
- Residue Analysis
- Active Ingredient Identification and Confirmation
- Potency
- Excipient Distribution and Authenticity
- Others
Labels
Packaging
Drug Product Analysis
See below for data examples.
| Typically Utilized Contaminant, Counterfit and Unknown Materials Analysis Techniques |
|
RAMAN and IR
Microscopy
Chemical imaging and micro and macro product mapping, matching to spectral libraries of authentic materials. Learn more about spectroscopic techniques, click here. |
| Scanning Electron Microscopy & CryoSEM
Analyze hydrated samples. Learn more about SEM techniques, click here. |
|
SEM/Electron Dispersive X-Ray
Micro Elemental Analysis. Learn more about elemental analysis techniques, click here. |
| Optical and Digital Microscopy
Still and dynamic image capturing. Learn more about microscopy techniques, click here. |
|
FT-IR with ATR,
Diffuse reflectance, transmission, gas cell, matching to spectral libraries. Learn more about spectroscopic techniques, click here. |
| Mass Spectrometry
GC/MS, LC/MS, LC/MS/MS and MALDI, matching to libraries - chemical identification. Learn more about MS techniques, click here. |
Application Notes:
Identification of Cellulosic Fibers by Infrared Spectroscopy and Scanning Electron Microscopy
This application note demonstrates how scanning electron microscopy (SEM) can be used in conjunction with Infrared (IR) micro spectroscopy to identify different cellulosic fibers based on surface features and overall fiber appearance.Download the application note!
Mini Case Study #1.
Goal: Determine whether a submitted final dosage container is authentic or possibly a counterfeit. A multi-disciplinary approach was used: Visual inspection, Optical microscopy, Infrared spectroscopy, Raman spectroscopy.
Figure 2. Comparison of the ink application for a section of the suspect (top) versus authentic (bottom) label. Raman Spectral comparison of ink on both (black) authentic and (red) suspect labels (bottom spectrum).
Figure 3.
Induction seal IR spectral comparison comparison of both (black) authentic and (red) suspect seals.
Conclusion: Authentic Materials; production run variations in packaging caused by using a different printing company were the source of differences. A multi-disciplinary approach was used:
- Multiple aspects of the label, container, and seal used to determine authenticity
- Establish basis sets for authentic materials
Mini Case Study #2.
Goal: Identify suspect tablets as authentic or counterfeit. An open container of final dosage product was submitted in which three tablets appeared suspect. Physical measurements and color of the tablets showed that they were not authentic.
- Visual Comparison; Suspect Tablets vs. Authentic Reference
- Embossing: None versus “xxx” on one side, “xxxx” on the other side for authentic
- Physical size: 19 x 10 mm versus 14.48 mm length, 10.51 mm width, 5.59 mm height
Chemical Identification was performed to attempt to identify the chemical components of the suspect tablet.
Figure 4.
Raman Spectral Analysis. Black: library spectrum of Pfizer's Viagra. Red: suspect tablet. Green: library spectrum of microcrystalline cellulose.
Conclusion: Counterfeit tablets. A multi-disciplinary approach was used:
- Counterfeit tablets identified as sildenafil citrate (active in Viagra) with MCC and titanium dioxide.
- Visual inspection: Color: Pink versus orange (brand color), tablet measurement, and comparison to reference authentic materials.
- Raman spectroscopy with spectral library matching.
Download The Publication Entitled "Chemical Identity Testing" In Applied Spectroscopy by David E. Bugay, Ph.D
