| Launch：2023-12-15 |
Research background
Near infrared light (Near-infrared-NIR) is an electromagnetic wave between ultraviolet-visible light and medium infrared light. The American Society for Materials and testing defines its wavelength range as 780-2500nm. Near infrared spectroscopy is mainly based on the frequency doubling and combined absorption of organic compounds. The near-infrared spectrum is mainly caused by the anharmonic vibration of the molecular vibration, which causes the molecular vibration to transition from the ground state to the high energy level. The most commonly observed band in the near-infrared region is the hydrogen-containing group. The anharmonic constants of the stretching vibrations of C-H, N-H, O-H, S-H andC=O, C=C are very high.
The inspection of API storage has become a routine application of near infrared spectroscopy. For example, the identification of medicinal excipients, the identification of API and the analysis of final products, especially after the promulgation of the new version of GMP, will have a wide range of applications in the rapid identification and release of medicinal excipients.
Application case
Mixing uniformity is one of the key operations that affect the quality of drugs. The guidelines are tedious and complex, requiring 10 sampling points, and each point should be repeated at least 3 times; each sampling point should be repeated twice and the sampling point should include each area of the mixing tank. This guiding principle requires high operation and has a certain impact on the production cycle of the product. As a rapid analysis technology, near-infrared spectroscopy has been more mature in the study of mixing uniformity, and there are practical application cases in pharmaceutical factories.
Oceanhoodi on-line near infrared analysis system is suitable for on-line analysis applications in pharmaceutical factories, petrochemical industry and material preparation fields. the system consists of TS9214 near infrared spectrometer, variable optical path immersion transmission probe and power adjustable halogen tungsten lamp. The TS9214 near-infrared spectrometer uses a fixed transmission grating to ensure high-throughput and high diffraction efficiency, with a wavelength coverage of 900-1700nm, a full-spectrum resolution＜3.5nm (25 μ m slit), and a high sensitivity and stable working state in the near-infrared region. TS9214 can also be replaced by TS11478, the wavelength range covers 1700~2500nm, and the resolution is < 6nm.
On-line Detection of moisture in Fluidized bed granulation process
Particle size-PVC resin particle size
Content analysis of API components
The mixed drug of duloxetine provided by Chinese and western pharmaceuticals was tested, the quantitative model of API was established, and the mixed end point was judged. TS11478 near infrared spectrometer (band 1700-2500nm) was used.
Application characteristics of near Infrared Spectroscopy
The speed of analysis is fast, and most of the measurement process can be completed in 1min.
The analysis efficiency is high. Through a spectral measurement and the established corresponding correction model, multiple components or properties of the sample can be determined at the same time, and the qualitative and measurement results can be provided.
It is suitable for a wide range of samples, and the samples of different substances such as liquid, solid, semi-solid and colloid can be measured directly through the corresponding sampling devices, and the spectral measurement is convenient.
Samples generally do not need pretreatment, do not need to use chemical reagents or high temperature, high voltage, high current and other test conditions, after analysis will not produce chemical, biological or electromagnetic pollution.
Low analysis cost and good test reproducibility.
It has no damage to the sample and can be widely used in in vivo analysis and medical clinical fields.
Near-infrared light has good transmission characteristics in ordinary optical fiber, so it is easy to realize on-line analysis.
The requirements for operators are not stringent, and they can be competent after simple training.
The extinction coefficient is weak, and the ability of long wave to penetrate the sample is strong (the deepest can reach 5cm).
Reference
[1]臧恒昌. 近红外光谱分析技术在肝素钠生产过程中的应用研究[D].山东大学,2013.
[2]王小亮,张秉华,邓玉龙,牛龙青,绳金房.诺氟沙星胶囊近红外在线质量控制初探[J].中国药业,2022,31(14):83-88.
