| Launch：2019-07-26 |
* Introduction
In the field of pharmaceuticals, the identification or verification of finished products, raw materials and excipients and their packaging materials is very important, and the rapid detection field is mainly spectral identification or verification of samples. 《Pharmaceutical Production Quality Management Specification (2010 edition)》 clearly stipulates that the relevant operational procedures should be formulated, and appropriate measures such as checking or inspection should be taken to ensure that the raw materials and accessories in each package are correct. The new version of GMP in the identification of raw materials and accessories, to ensure that the content of raw materials and packaging identical with the logo, is an important control target for material storage receipt, based on the actual production control needs, enterprises can be based on the principle of risk control, adopt one or more means to ensure the correctness of materials.
At present, the whole industry is still unable to identify every minimum package of raw materials and accessories purchased according to the requirements of GMP. The compliance of the regulations is poor. It can only be identified by sampling and sending to the laboratory. At present, most pharmaceutical factories adopt mid-infrared spectroscopy, which requires sample pretreatment, and the time period is comparatively long. Long. Raman spectroscopy line edge detection technology, with fast, non-destructive, non-contact, non-disassembly packaging direct measurement, makes the minimum package inspection possible.
* Application
Raw material: hydroxychloroquine sulfate
Accessories: talcum powder, polyvinyl ketone, hydroxypropyl methyl cellulose, lactose, sodium carboxymethyl starch, microcrystalline cellulose, corn starch and magnesium stearate.
EVA3000Plus、Raman solid measurement support
Handheld Raman spectrometer EVA3000Plus produced by Shanghai Ruhai Photoelectric Technology Co., Ltd..
Instrument parameters:
| Physical parameters | |
| Size | 180*95*38mm |
| Weight | <800g |
| Input interface | Micro USB |
| performance parameter | |
| Spectral range | 200 cm-1～3200cm-1 |
| Wavelength resolution | 15cm-1 @1000 cm-1 |
| Excitation wavelength | 785±0.5nm，Linewidth＜ 0.1nm |
| Laser lifetime | 10,000.00hrs |
| Voltage | DC5V Electric adapter |
| Output power | 0~500mW self-adaption |
| Integral time | 1ms-10S self-adaption |
| Probe Rayleigh scattering cut-off depth | OD6 |
| Probe focal length | 7.5mm |
| Camera | 8 million pixels |
| Touch screen | 720*1280 Resolution capacitance screen |
| Three defense standards | IP65 |
| Network | 4G/WIFI/Bluetooth/GPS |
| Environmental parameters | |
| Working temperature | 0 ~ 45℃ |
| Working humidity | 5%-80% |
The Raman spectrograph of pharmaceutical raw materials and excipients was obtained by using the Raman fixed measuring probe and the probe of EVA3000Plus, close to the self-sealing bag and pressing the data acquisition button.
* Result discussion
The Raman spectra of 9 common raw materials and accessories were detected by EVA3000Plus. The built-in software used fluorescence background subtraction, spectral smoothing and other algorithms to preprocess the spectra, as shown below:
The Raman spectra of different raw materials and excipients have different characteristic peaks, and the distinction between different raw materials and excipients is high. The correlation coefficients of Raman spectra of nine common raw materials and excipients are calculated. The results are as follows:
<td width="46.33333333333333" valign="top" style="line-height: 1; box-sizing: border-box; margin: 0px; padding: 0px; border-left: none; border-right-style: outset; border-right-color: windowtext; bo
French chalk | povidone | Hydroxychloroquine sulfate | hypromellose | corn starch | lactose | Avicel | Magnesium stearate | |
French chalk | 1.00 | 0.19 | 0.03 | 0.15 | 0.15 | 0.24 | 0.18 | 0.17 |
povidone | 0.19 | 1.00 | 0.38 | 0.30 | 0.39 | 0.26 | 0.25 | 0.35 |
Hydroxychloroquine sulfate | 0.03 | 0.38 | 1.00 | 0.45 | 0.35 | 0.21 | 0.47 | 0.14 |
hypromellose | 0.15 | 0.30 | 0.45 | 1.00 | 0.66 | 0.47 | 0.66 | 0.50 |
corn starch | 0.15 | 0.39 | 0.35 | 0.66 | 1.00 | 0.71 | 0.65 | 0.40 |
lactose | 0.24 | 0.26 | 0.21 | <span style="line-height: 1; box-sizing: border-box; margin: 0px; padding: 0px; color: rgb(51, 51, 51); letter
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