Related Experiment Video
Updated: Dec 30, 2025
09:59
Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
18.5K
Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld
Adam Lanzarotta1, Martin M Kimani1, Michael D Thatcher1
1Forensic Chemistry Center, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food & Drug Administration, Cincinnati, OH, 45237.
Journal of Forensic Sciences
|January 28, 2020
Summary
Handheld Raman devices accurately identify authentic (CWA) and not consistent with authentic (NCWA) pharmaceutical tablets. This field-friendly method enables rapid screening, aiding in drug interdiction and supply chain security.
Area of Science:
- Analytical Chemistry
- Forensic Science
- Pharmaceutical Analysis
Background:
- Illicit pharmaceutical tablets pose significant public health and safety risks.
- Field-deployable analytical tools are needed for rapid identification of counterfeit or substandard drugs.
- Handheld Raman spectroscopy offers a non-destructive, rapid analytical technique suitable for field use.
Purpose of the Study:
- To evaluate the performance of handheld Raman devices for differentiating authentic (CWA) and not consistent with authentic (NCWA) pharmaceutical tablets.
- To assess the efficacy of a parent-daughter electronic transfer method for deploying analytical methods to field devices.
- To determine the suitability of this technology for non-expert users in real-world scenarios.
Main Methods:
- Handheld Raman devices ('parent' devices) were used to analyze 25 authentic and 84 known NCWA tablets (327 analyses).
- Analytical methods and libraries were transferred electronically to 13 'daughter' devices.
- Daughter devices analyzed 10 suspect finished dosage forms (6 NCWA, 4 authentic) in duplicate (260 measurements).
Main Results:
- Parent devices achieved high accuracy: 100% true pass rate, 98.4% true fail rate, 1.6% false pass rate, 0% false fail rate.
- Daughter devices demonstrated strong performance post-transfer: 100% true pass rate, 95.5% true fail rate, 4.5% false pass rate, 0.0% false fail rate.
- The parent-daughter transfer method proved successful, enabling consistent performance across devices.
Conclusions:
- Handheld Raman spectroscopy, coupled with electronic method transfer, provides a reliable field-based solution for identifying suspect pharmaceutical tablets.
- This technology can prioritize samples for further laboratory testing and support interdiction efforts at points of entry.
- The developed method empowers non-experts to rapidly screen pharmaceuticals, enhancing supply chain security and public safety.
Keywords:
TruScanauthenticity testingcontrolled substancescounterfeit pharmaceuticalsforensic chemistryhandheld Raman spectrometersMore Related Videos
Related Concept Videos
01:26Raman Spectroscopy Instrumentation: Overview
939
A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
939
01:20Raman Spectroscopy: Overview
1.2K
The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
However, a small fraction of the scattered light exhibits a frequency shift due to the exchange of energy between the incident photons and...
However, a small fraction of the scattered light exhibits a frequency shift due to the exchange of energy between the incident photons and...
1.2K
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
114
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
114
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
193
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
193