Excipient Quantification and Identification

Excipients comprise a wide range of compounds with different chemical structures and mechanisms of action, some of which act as bulking agents, some enhance the absorption of active ingredients, and some prevent denaturation over a product's expected shelf life. Due to this functional diversity, excipients are used in pharmaceutical products with different applications. However, the diversity of excipients presents unique challenges when it comes to laboratory analysis. Nevertheless, the pharmaceutical industry must be able to reliably characterize many classes of excipients in order to introduce effective products to market. To safely and efficiently produce drug products that meet regulations and standards, a range of spectroscopic, microscopic, chromatographic and electrophoretic techniques are employed to identify and characterize diverse excipients.

Figure 1. New Possibilities for Pharmaceutical Excipients Analysis.

Our Capabilities

Analysis of the composition of pharmaceutical excipients often involves a range of spectroscopic techniques to determine the molecular and chemical composition. Only by using all these techniques can a reliable determination of the composition be accomplished.

Spectroscopy-based Excipient Composition Analysis

Molecular spectroscopy plays an important role in the physical characterization of pharmaceutical excipient solids. A wide range of spectroscopic techniques allows for accurate and rapid determination of molecular and chemical composition. Thanks to our expert team's extensive project experience in Near Infrared and Raman Spectroscopy, BOC Sciences is able to accurately interpret spectral data for the most commonly used excipients in pharmaceutical formulations by identifying the observed spectral features.

• Raman Spectroscopy Analysis

We have introduced Principal Component Analysis (PCA), Deep Learning (DL) and Non-Negative Least Squares (NNLS) methodologies for the full interpretation of the obtained Raman spectral data to provide our customers with the most comprehensive identification of excipients.

• Near Infrared (NIR) Spectroscopy

In recent years, the development of NIR reflectance spectroscopy has accelerated the identification of pharmaceutical excipients. Based on advanced NIR spectroscopy instruments and comprehensive spectral data of different types of pharmaceutical excipients, we are able to achieve 100% classification of drug components and excipients.

Chromatography-based Quantitative Analysis of Excipient

Advances in chromatography and methods have provided scientists with innovative ways to overcome the challenges of excipient quantification and support the production of therapeutic drugs suitable for clinical use. BOC Sciences has introduced a range of chromatographic instruments and equipment including, but not limited to:

• Size Exclusion Chromatography (SEC) - Infrared (IR) Spectroscopy

For polymeric excipients, we use SEC technology for separation, and the obtained polymeric components are detected by IR spectroscopy.

• Gel Permeation Chromatography (GPC) - Fourier Transform Infrared (FTIR) Spectroscopy

Many copolymers are often used as excipients in pharmaceutical formulations. These copolymers can be analyzed by a combined method of GPC and FTIR. The molecular structure maps obtained by GPC separation can be used to characterize the distribution of monomers in the sample.

• High Performance Liquid Chromatography (HLPC) - Charged Aerosol Detector (CAD)

At BOC Sciences, our experts use a combination of HLPC and CAD technology for the separation and quantification of non-volatile substances in excipients.

• HPLC-Evaporative Light Scattering (ELS)

An increasing number of nanomedicines are currently being designed and developed for the treatment of diseases. We therefore introduce an HPLC method combined with an ELS detector and a UV-Vis detector for the analysis of excipients in nanomedicines, including nanoparticles encapsulating phytotherapeutics, liposomes encapsulating immune promoters, and PEGylated peptides.

• Ultra-High-Performance Liquid Chromatography(UHPLC)-High Resolution Mass Spectrometry (HRMS)

Our chromatography department has developed a UHPLC-HRMS method for the rapid identification of nonionic surfactants, such as polysorbate. In addition, we have developed a mathematical model to predict all possible components of the excipients.

• High-Performance Anion-Exchange Chromatography (HPAEC) - Pulsed Amperometric Detection (PAD)

For the identification of sugar-based excipients, our team of experts has developed a new HPAEC-PAD analytical method that can accurately analyze carbohydrate-based excipients.

De-formulation/Reverse Engineering of Excipient

We provide excipient reverse engineering services by breaking down a drug product formulation into individual components to determine the specific identity and quantity of each component. Based on our experts' in-depth knowledge of excipient properties and BOC Sciences' specialized analytical laboratory facilities, we are able to provide quantification of excipients and accurate identification of individual excipients in drug formulations. We offer high-quality reverse engineering services by employing physicochemical methods and advanced sample preparation techniques that cover many different excipients. Moreover, in addition to identifying and quantifying individual excipients in complex drug formulations, we are able to identify excipient grades and excipient quality.