Applications

Pharma Forensics Solutions for Product Integrity and Risk Mitigation

Pharmaceutical manufacturers face growing pressure to minimize product risk across the entire value chain—from raw material sourcing to final dosage forms. Impurities, cross‑contamination, counterfeit compounds, formulation inconsistencies, and raw material variability all pose significant threats to patient safety, regulatory compliance, and brand integrity. Yet many organizations still rely on incomplete analytical coverage or outdated testing methods, leaving critical blind spots in quality and forensic investigations.

The Need for Advanced Pharma Forensics

Modern pharma forensics demands:

Rapid identification of unknowns and contaminants
Verification of raw materials and excipients
Authentication of finished products and packaging
Non‑destructive analysis for scarce or high‑value samples
Traceability and defensible analytical data

To meet these demands, pharmaceutical quality, analytical, and forensic teams require robust, complementary analytical technologies that deliver speed, confidence, and reproducibility.

HORIBA’s analytical tools help pharmaceutical organizations move beyond reactive testing toward proactive risk mitigation and forensic readiness—without sacrificing speed or sample integrity.

Helping Our Customers

Exposing Counterfeit Drugs

Integration of sophisticated spectroscopic tools into the lab are being used not just to authenticate products, but to actively detect counterfeits.

Raman Spectroscopy identifies unknown particles in the food and drug supply

Raman gets the goods on counterfeiters

Mark Witkowski of the U.S. Food and Drug Administration’s Trace Examination Section uses HORIBA Raman spectroscopy to tackle counterfeit pharmaceuticals, supplements, and contaminated foods. Employing non-destructive micro-Raman (LabRAM IR2) and automated XploRA PLUS with ParticleFinder™, his team rapidly analyzes small particles and tablets.

MacroRAM Affordable Benchtop Raman Spectrometer

Weeding out Over-the-Counter Frauds

Dr. Sayo Fakayode of Georgia College & State University applies portable Raman spectroscopy combined with chemometric tools—regression and principal component analysis—to screen over-the-counter medicines and supplements. His approach rapidly detects and quantifies active ingredients in common OTC products, achieving approximately 94 % accuracy.

Researcher fights food fraud

Gene Hall is a crusader. His mission is to find mislabeled food and dietary supplement products, and reveal them to the world.

Only HORIBA provides a full‑suite, multi‑modal forensic toolkit

Elemental Analysis

Trace element detection, impurity profiling, heavy‑metal contamination analysis, packaging interactions

Fluorescence Analysis

Detecting degradation, excipient variability, counterfeit signatures, fluorescence‑active impurities

Particle Characterization

Detecting formulation inconsistencies, verifying particle size distribution for dissolution/absorption integrity

Raman Analysis (including AFM)

Contaminant ID, polymorph detection, counterfeit ingredient verification, raw material authenticity

HORIBA analytical platforms and workflows support inspection‑ready pharmaceutical operations, including:

cGMP Support
- Consistent, reproducible analytical performance
- Controlled workflows suitable for regulated QC and forensic labs
- Clear documentation supporting deviations, investigations, and CAPAs

Pharmacopeia Alignment
- Support for compendial identification and verification approaches
- Complementary techniques for risk‑based testing strategies

FDA & EMA Testing Expectations
- Scientifically robust methods appropriate for confirmatory analysis
- Analytical techniques widely accepted by global regulators
- Data suitable for inclusion in regulatory submissions and responses

ICH Impurity Control
- Sensitive detection of elemental and process‑related impurities
- Data supporting risk assessment and root‑cause analysis

Webinars

Particle Correlated Raman Spectroscopy: Unlocking the Full Picture of Particulates in Pharmaceuticals

Fluorescence A-TEEM Method for Vaccines Characterization

Raman Microscopy: A must for pharmaceutical product analysis, from formulation studies to QC

Size, Chemistry, and More: Raman and Laser Diffraction for Pharma Particle Analysis

Application Notes

Monitoring Cell Culture Media Variability using A-TEEM Spectroscopy

Cell culture media for bioreactors are commonly prepared as aqueous solutions that provide the essential nutrients and conditions required for optimal cell growth, product yield, and quality. Even subtle variations in media composition can significantly impact cell growth rates and yield. Consequently, the identification and analysis of cell culture media are critical for maintaining consistency and optimizing performance.

This study demonstrates the potential of A-TEEM™ spectroscopy as a rapid and reliable tool for evaluating lot-to-lot variability in complex cell culture media. By leveraging the distinct spectral fingerprints of aromatic amino acids and vitamins, A-TEEM enables sensitive tracking of compositional differences without the need for extensive sample preparation or lengthy separations.

High-Throughput Quantification of Pharmaceutical Powder Blends Using Raman Spectroscopy and Chemometrics - Illustration

Raman spectroscopy combined with chemometric modeling enables high-throughput, non-destructive quantification of excipient composition in pharmaceutical powder blends.

Drug Qualification by Raman Microscopy: Advanced Approaches for Rapid Analysis and Characterization - Illustration

Raman microscopy combined with high-throughput acquisition enables rapid, non-destructive drug qualification and chemical characterization of pharmaceutical tablets.

Application note illustration: 3D Confocal Raman Microscopy for Detection of Minor Crystalline API Form in a Pharmaceutical Extrudate

3D confocal Raman microscopy enables non-destructive detection and spatial localization of minor crystalline API forms within pharmaceutical extrudates, supporting comprehensive solid-state characterization.

Analysis of Morphology and Chemical Identification of Pharmaceutical Micro-particles Using Particle Correlated Raman Spectroscopy - Illustration

This study highlights particle correlated Raman spectroscopy (PCRS) as a powerful technique for combining particle characterization with chemical identification, enabling deeper insight into drug performance across various pharmaceutical dosage forms (sprays, tablets, creams).

During the last 5-10 years, the molecular solid state has gained recognition by the pharmaceutical industry for its role in drug manufacturing, stability, and activity. In addition, definition of the crystalline phase has become as important as molecular composition in patent protection.

Polymorphisms characterization: when Raman microscopy supports the pharmaceutical industry

Since the physical state can affect the pharmaceutical behavior of drug substances, it is important to know what controls crystallization, solid state reactions, phase stability, and solubility.

Raman Spectroscopy is a powerful and widely used analytical tool within the pharmaceutical industry. Excipients and active pharmaceutical ingridients (APIs) can be analysed within seconds, and extensive Raman spectral libraries allow easy chemical identification.

Raman Analysis of lysozyme

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

The objective of the measurements is to identify the unknown components and their respective dispersion within pharmaceutical tabs by Raman and FT-IR microspectrometry.

Resulting from the combination of Raman spectroscopy and optical microscopy, Raman hyperspectral imaging has proven to be an indispensable tool in the pharmaceutical field, especially to study the distribution of active(s) and excipients in a pharmaceutical drug product.

Application note: Morphological and chemical characterization of pharmaceutical formulations

One of the major challenges in the pharmaceutical development of a new product consists in its formulation, highly impacting the release and the efficiency of the active molecules in the body.

For the study of a pharmaceutical drug product, particle characteristics (count, size and chemistry) and compound distributions (size and spatial) are among key parameters that strongly determine the quality of the product due to their huge impact on the dissolution rate (and thus bioavailability) for the final solid dosage form. Laser diffraction and Raman microscopy were applied to highlight the benefits of combining two technologies for particle characterization.

Full and detailed characterization of pharmaceutical formulations is required before release of new drugs. When exposed to warm and humid weather over time, ingredients may undergo change in their hydration level, thus affecting the properties and/or efficiency of the drug. Raman spectroscopy, combined to a temperature and humidity controller can mimic such harsh conditions and can be used to monitor the properties of the different ingre-dients and track their modifications induced by environmental changes.

Quality control of hand sanitizer gels and 70% alcohol products using Raman spectroscopy

Disinfecting your hands with hydroalcoholic gel has become a daily practice. In the meanwhile, 70° alcohol has been used for even longer to disinfect wounds. But, to remain efficient, the alcohol concentration of these products must not be below a defined threshold and must be controlled. This application note demonstrates how to evaluate alcohol concentrations in a quality control process with Raman.

Raman Spectroscopy has many useful properties which can be explored and exploited in the analysis of pharmaceutical formulations.

Raman spectra of DayQuil™ and NyQuil™ collected with an immersion probe fiber-coupled to the MacroRAM™ Raman spectrometer, and a picture of the immersion probe setup.

Raman spectroscopy is well known as a powerful analytical method for qualitative chemical analysis. Less well known is that under certain conditions Raman spectroscopy can also be an effective method for quantitative analysis. Here we demonstrate that capability for quantitative analysis under a variety of conditions, involving different solutes in a solution and solution mixtures, and its applications to pharmaceutical analysis such as content uniformity.

Raman Microscopy in Pharmaceutical Salt Analysis

Pharmaceutical and crystallographic samples typically require detailed characterisation and analysis to optimise a samples stability, physical properties and indeed general efficacy where an active drug substance is involved. Furthermore, strict regulatory and manufacturing procedures demand precise characterisation of a solid salt form drug candidate and the possible influence of environmental conditions. The hydration and structure of such samples under varying conditions is important in this full characterisation.

Raman Hyperspectral Imaging: An essential tool in the pharmaceutical field

Resulting from the combination of Raman spectroscopy and optical microscopy, Raman hyperspectral imaging has proven to be an indispensable tool in the pharmaceutical field. This article will broach a number of Raman hyperspectral imaging applications that were developed in our laboratory, in order to demonstrate the significance of the technique.

Mineral-based sunscreens have gained popularity due to their excellent ability to scatter ultraviolet (UV) rays without causing photo-induced skin irritation from chemical-based sunscreens. Three over-the-counter zine oxide sunscreens were purchased and analyzed using Partica LA-960V2 Laser Diffraction Particle Size Analyzer. A standard 15 mL fraction cell accessory fitted with a magnetic stir bar was chosen for this experiment.

Zeta potential is a key physical parameter that describes surface charge on proteins. Although there has been interest in measuring the zeta potential of proteins for many years, the measurements were often difficult due to a variety of reasons including the “cooking” of proteins on the cell electrodes when using light scattering techniques.

Protein aggregation is an important concern when developing and manufacturing biotherapeutics since these subvisible aggregate particles have been associated with the adverse drug reactions. Protein aggregates may provoke adverse events through an unwanted immune response. And, regardless of mechanism of reaction, subvisible particle contamination has been a concern for manufacturers and regulators.

In this Application Note, we will focus on the importance of monitoring particle size and distribution range throughout two different processing technologies used to improve shelf-life and efficacy of CBD products.

Sub-visible Particles from ViewSizer 3000

The ViewSizer 3000 enables scientists to visualize and quantify the kinetics of protein aggregation in real-time for biologic therapeutics under a variety of stress conditions including agitation, temperature and the addition of contaminants. The case study featured here validates these capabilities for agitation and temperature stress conditions with the 100 mg/mL mAb A.

Successful ophthalmic drug delivery is a combination of pre-corneal retention time, corneal permeability, effectiveness of drug absorption, and dose-to-dose consistency. Whether the drug product is a suspension or microemulsion, it is a complex application involving careful analyses, research, and development efforts.

A virus particle consists of several parts including the genetic material (DNA or RNA), a protein coat that protects these genes, and in some cases an envelope of lipids that surrounds the protein coat when they are outside a cell. The size of viruses ranges from a few tens to a few hundreds of nm, which is equal to 1/100 to 1/1000 of the cell (a few to a few tens of μm in size) of any other common living organism.

The complexity of viral particles remains one of the biggest hurdles in the development process. In this note, the upstream process of analyzing viral preparations is addressed, as well as the use of multi-laser nanoparticle tracking analysis (NTA) as a cost and time efficient method to measure size, count virus particles, and correlate to infectious titer.

Size matters in vaccine delivery systems. Nanoparticles smaller than 200 nm generally present a greater immunogenic response than micro-particles larger than 1 micron. This rather simple statement is based on the common understanding that particles with sizes resembling the dimensions of viruses are treated like viruses by the body.

Exosomes are small extracellular vesicles, 30-150 nm in diameter, which have been determined to play a crucial role in extracellular signaling. They have been observed in both prokaryotic and eukaryotic organisms, meaning they are incredibly widely spread in nature. Exosomes bud off from their parent cells in a sealed package, taking the properties of their parent cell walls with them and encasing many intracellular components.

In this study, we demonstrate the ViewSizer 3000’s capabilities as a next generation NTA based analysis instrument in order to accurately and efficiently measure and characterize extracellular vesicles (EV) via particle size and concentration.

Back to top.

Request for Information

Do you have any questions or requests? Use this form to contact our specialists.

First name

Last name *

Company or Institution *

Postal code *

City

Country/Region *

State

Email address *

Phone

HORIBA Department

Your message *

I have read and agree to the HORIBA privacy notice

* These fields are mandatory.