Hand-held Raman spectrometer: a powerful tool for quality control of APIs

Abstract: Cheap and fast handheld Raman spectrometers are quickly becoming a powerful tool for quality control of API procurement.

Raman Spectrometer is a powerful tool for rapid identification of unknown compounds, such as the detection of high-purity chemicals, drug composition verification and characterization of polymer materials. The popularity of Raman spectroscopy instruments is mainly due to the intelligent decision-making software and spectrum libraries equipped with modern instruments, making it an ideal molecular fingerprint analysis technology. Unlike traditional molecular spectroscopy techniques, Raman spectrometers can be used in production environments or on-site applications because they can produce sharp, specific spectral peaks that require little sample preparation or direct contact with the sample. In addition, it also has a unique ability to directly test samples through transparent packaging materials, such as glass or plastic, without any interference with spectral information.

Today's Raman spectrometers are developing in the direction of faster, more durable, cheaper, and miniaturized components, which has prompted the emergence of high-performance, portable, handheld Raman spectrometers. These handheld devices are particularly suitable for applications in the pharmaceutical field, such as testing of raw materials, final product verification, and identification of counterfeit drugs, because Raman spectroscopy has a very high molecular selectivity.

Figure 1: Raman spectra (from top to bottom) of five similar organic molecules: acetone, ethanol, dimethyl sulfoxide, ethyl acetate and toluene.

Traditional medical raw material quality control generally requires sampling to the laboratory for testing or using portable infrared equipment to test the chemical composition of selected batches of samples. In addition, the final product verification of drugs requires more rigorous methods and requires skilled chemical analysis operators to be able to perform extraction operations and use complex and time-consuming analytical techniques such as wet chemical analysis, liquid chromatography or Mass spectrometry etc.

Although the existing analysis methods have achieved satisfactory results, their analysis speed is extremely slow, not cost-effective, and has a huge sampling bottleneck, especially as the FDA encourages all pharmaceutical companies to test each A box of APIs. For this reason, analytical instrument companies have been working with the pharmaceutical industry to develop innovative solutions for many years to replace current detection methods, improve analytical goals, and reduce overall costs.

There is no doubt that Raman spectroscopy is the most suitable technology for this type of work. It can quickly determine whether the ingredients of the API or final drug are real through the built-in spectrum library or the user-generated spectrum library. With the development of small handheld devices, this technology can be used anywhere in a manufacturing plant to quickly provide the operator with the chemical properties of the material.

The development of various technologies has promoted the progress of portable Raman spectroscopy instrument technology, making the instrument very suitable for the characterization of APIs. These technologies include: advanced manufacturing procedures, innovative optical design, compact and highly stable detectors, smaller electronic components, the development of touch screens, advances in computing power, and batteries that last longer and perform better.

Raman Spectrometer is becoming a powerful analytical tool for quality control in the procurement of APIs. The reason it is widely accepted is that it is used for rapid identification of warehouse chemicals and is more cost-effective than traditional laboratory analysis techniques. Many manufacturing companies have found that the initial investment cost recovery period of the instrument is only 6 to 12 months.