Sponsored Content by Specac LtdReviewed by Maria OsipovaMar 5 2025
Quantifying the Active Pharmaceutical Ingredient (API) in a finished product is critical to ensure that consumers obtain the correct dosage. Too little dosage may limit its effectiveness, and too much dosage may increase the risk of overdose.
Fourier Transform Infrared (FTIR) spectroscopy provides rapid and cost-effective testing of many pharmaceuticals, especially when combined with accessories saving transmission and time. Recently, the testing of Simethicone in medicinal foundations found in the high street demonstrated the ability of FTIR.
Image Credit: Specac Ltd
Simethicone is classified as an over-the-counter medication that relieves excess gas, which is prevalent in people with irritable bowel syndrome or babies with colic. Its anti-foaming properties provide the medication with many applications in pharmacology, and it is generally considered safe 1.
One application of Simethicone is that it can be given before endoscopy exams to help reduce bubbles and foam in the gastrointestinal tract 2. Pharmacopoeia standards will inform on the thresholds to follow for different medicines. As a result, the concentrations, molecular weight, and viscosity of medicines need to be measured 2.
Standards that describe the required labeling of these compounds also exist, such as CFR Title 21, Volume 5, Part 332 in the USA. The European Pharmacopoeia standard 10.0 (01/2017:1470) describes the FTIR measurement of simethicone that has been extracted into an organic, toluene phase that is then compared to a known concentration
To test the high street availability of simethicone, two different formulations of commercially available simethicone were obtained. The corresponding %API content was then measured relative to a reference sample of known concentration.
Ahead of the test, the Specac’s Pearl™ liquid transmission accessory was attached to the FTIR spectrometer. This accessory is ideal for repeated measurements of liquid samples due to its horizontally mounted measurement cell (referred to as the Oyster™). Moreover, the Oyster™ can be opened for sampling or cleaning and closes each time to a defined and repeatable pathlength without tools or fasteners.
The results of the FTIR corresponded to the stated dosage on the label. Therefore, the test results confirm the validity of the method, and the suitability of using the Pearl for use. For any analytical testing laboratory, the Pearl facilitates the procedure for obtaining an FTIR spectrum of a liquid at a specific pathlength and provides higher sample throughput benefits as a result.
References
- European Pharmocopoeia 11.0, Simeticone (2022)
- Bhamla, M.S., et al. (2017). Hand-powered ultralow-cost paper centrifuge. Nature Biomedical Engineering, (online) 1(1), pp.1–7. https://doi.org/10.1038/s41551-016-0009.
About Specac Ltd
Specac manufactures an extensive range of FTIR Accessory, IR Polarizer, and Pellet Press Products for Atomic and Molecular Spectroscopy.
These products include ATR Accessories, Specular Reflectance Accessories, Diffuse Reflectance Accessories, Liquid Transmission and Gas Transmission Cells, as well as Infrared and Terahertz Wire Grid Polarizers, Bench-Top Hydraulic Presses, KBr Pellet Presses, XRF Pellet Presses, Thin Film Making Kits, and Evacuable Pellet Dies.
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