Analytical Method that Enables Over-the-container Identification of Pharmaceutical Additives

Introduction

Polysorbate is used as a solubilizer and stabilizer in pharmaceuticals. Because polysorbate is sensitive to light and air, it is typically stored in closed, light-shielded containers such as brown bottles. Identification of such raw materials requires sampling by opening the package, which creates the risk of loss of sterility and quality deterioration. In addition, the time and effort required for pretreatment and measurement is also a burden on the field. Portable Raman spectrometers that can quickly and nondestructively identify raw materials through their containers are attracting attention.

Chemical fingerprinting

Figure 1: Analysis of Polysorbate 20 (JT Baker) in a 200 ml brown bottle
785 nm and 1064 nm

Conclusion

As shown in Figure 1, conventional 785 nm Raman spectroscopy has difficulty in discriminating Polysorbate 20 through a brown bottle due to the fluorescent background. However, Raman spectroscopy using 1064 nm excitation produces a clear peak and enables highly accurate identification even through the container. 1064 nm Raman spectroscopy is an effective means of both on- site operability and reliability in the incoming inspection of light-sensitive liquid materials.