An online near-infrared (NIR) raw material analyzer is an instrument that uses near-infrared spectroscopy technology to analyze the quality, composition, and other properties of raw materials (APIs) or their mixtures in real time. Near infrared technology, with its non-destructive, fast, and real-time characteristics, is widely used in the pharmaceutical industry for production process monitoring, quality control, and other fields. The following is the application principle of online near-infrared raw material analyzer:
1. Principle of Near Infrared Spectroscopy Technology
Near Infrared Spectroscopy (NIR) is a technique that uses near-infrared light (700nm-2500nm) to irradiate a sample. The sample absorbs and scatters light of different wavelengths, and then analyzes the chemical composition and structure of the sample based on its absorption spectrum. The NIR spectrometer measures the absorption of near-infrared light of different wavelengths by the sample, obtains the reflection spectrum of the sample, and then analyzes it.
Principle details:
Vibration absorption: Near infrared light mainly interacts with molecular vibrations in the sample, such as stretching and bending vibrations of bonds such as C-H, N-H, O-H. Molecules with different chemical structures absorb near-infrared light differently.
Spectral peak characteristics: By analyzing the absorption peak position, intensity, width, etc. in the spectrum, information about the sample composition, content, structure, etc. can be obtained.
2. Working principle of online analysis
The basic working principle of an online near-infrared raw material analyzer is to directly or indirectly collect near-infrared spectral data of samples during the production process and provide real-time feedback on the analysis results. The specific process is as follows:
Light source illumination: The instrument emits light waves through a near-infrared light source, which illuminate the raw materials or samples in the production process.
Sample reflection/transmission: Samples absorb, scatter, and transmit near-infrared light based on their chemical composition and physical properties, producing different reflected light.
Spectral detection: The light reflected or transmitted by the sample is received by a sensor (such as a photodiode array), converted into an electrical signal, and then analyzed by a computer system.
Data processing: The computer system processes the collected spectral signals, compares them with known calibration curves or spectral databases, and quickly calculates key parameters such as sample composition, content, and uniformity.
3. Application of online near-infrared analyzer
The online near-infrared raw material analyzer can monitor and analyze the quality of raw materials in real-time during the production process, and its specific applications are as follows:
(1) Quality control of active pharmaceutical ingredients
Ingredient analysis: Analyze the active ingredients, excipients, and impurities in the raw materials through near-infrared spectroscopy. For example, analyzing the concentration of a certain active ingredient in a drug to assist manufacturers in quality control.
Purity testing: By measuring the near-infrared absorption characteristics of the sample, analyze whether there are impurities or unqualified components in the sample.
Moisture content detection: Near infrared technology has a very high sensitivity to moisture and can monitor the moisture content of raw materials in real time to ensure the dryness of the product during production.
(2) Real time process monitoring
Reaction process monitoring: The online near-infrared analyzer can monitor the real-time conversion of raw materials during the reaction process, automatically detect changes in active ingredients during the reaction process, to ensure the completeness of the reaction process and the stability of drug quality.
Mixing uniformity detection: During the mixing stage of drug production, near-infrared technology can be used to monitor the uniformity of raw materials in real-time, ensuring the homogeneity of the finished product.
(3) Quality control in the production process of solid preparations and tablets
Tablet hardness and composition testing: NIR can be used to monitor the composition distribution and hardness control of tablets in real-time during tablet production, ensuring consistency and quality of tablets.
Coating monitoring: Monitor the uniformity of the coating, check the thickness of the coating and whether it meets specifications.
(4) Production optimization and cost control
Improve production efficiency: By real-time online monitoring of the production process, reduce testing and sampling steps, accelerate production cycles, and reduce costs.
Automated control: Combined with feedback control systems, NIR analysis results can be used to automatically adjust key parameters of the production process, ensuring the stability of drug product quality.
4. Calibration and data analysis
The calibration of online near-infrared analyzers is a key step in ensuring the accuracy of measurement results. Through calibration, the equipment can accurately convert spectral data into sample composition and quality data. The usual calibration process includes:
Using standard samples: By measuring samples with known components, establish the relationship between reflectance spectra and components (such as using regression analysis, etc.).
Real time calibration: Regularly calibrate equipment based on changes in the production environment (such as humidity, temperature, etc.) to ensure the accuracy of data.
Data analysis model: By using statistical methods such as principal component analysis and partial least squares, the obtained spectral data is analyzed to obtain parameters such as drug composition and content.
5. Advantages of online near-infrared analyzer
Non destructive testing: No need to sample or destroy samples, reducing sample processing time.
Strong real-time capability: able to monitor the production process in real time, quickly provide feedback data, and ensure the control of the production process.
High throughput analysis: capable of analyzing a large number of samples in a short period of time, improving production efficiency.
High accuracy: able to provide high-precision composition and quality control information through calibration and data analysis.
Automation and Intelligence: Combined with automated production lines, it can achieve fully automated production process monitoring.
6. Conclusion
The online near-infrared raw material analyzer can perform efficient and non-destructive quality control and process monitoring in the drug production process by real-time acquisition and analysis of near-infrared spectra. This technology is widely used in quality monitoring, production process optimization, component analysis, and finished product testing of active pharmaceutical ingredients, helping pharmaceutical companies improve product quality and production efficiency.