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Application of handheld Raman EVA3000Plus in identification of raw materials

Launch：2019-07-26    

* Introduction

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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

Experimental reagents

Raw material: hydroxychloroquine sulfate

Accessories: talcum powder, polyvinyl ketone, hydroxypropyl methyl cellulose, lactose, sodium carboxymethyl starch, microcrystalline cellulose, corn starch and magnesium stearate. 

Experimental instrument

    EVA3000Plus、Raman solid measurement support

    Handheld Raman spectrometer EVA3000Plus produced by Shanghai Ruhai Photoelectric Technology Co., Ltd..

Instrument parameters:

Physical parameters
Size180*95*38mm
Weight<800g
Input interfaceMicro USB
performance parameter
Spectral range200 cm-1～3200cm-1
Wavelength resolution15cm-1 @1000 cm-1
Excitation wavelength785&plusmn;0.5nm，Linewidth＜ 0.1nm
Laser lifetime10,000.00hrs
VoltageDC5V Electric adapter
Output power0~500mW self-adaption
Integral time1ms-10S self-adaption
Probe Rayleigh scattering cut-off depthOD6
Probe focal length7.5mm
Camera8 million pixels
Touch screen720*1280 Resolution capacitance screen
Three defense standardsIP65
Network4G/WIFI/Bluetooth/GPS
Environmental parameters
Working temperature0 ~ 45℃
Working humidity5%-80%

 

 

Experimental method

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:

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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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