Active Pharmaceutical Ingredient

Characterization using SONICC®

SONICC (Second Order Nonlinear Imaging of Chiral Crystals) uses a femtosecond pulsed laser to exploit the frequency-doubling effect produced by the majority of Active Pharmaceutical Ingredients (APIs) and allows for 2-orders of magnitude improvement of sensitivity versus conventional techniques.

 

Unprecedented Crystallinity Sensitivity

 

SONICC was developed in collaboration with Purdue University that has unprecedented limits of detection for crystalline APIs. SONICC can detect 0.01% crystallinity whereas Powder X-Ray Diffraction can only detect down to 1% crystallinity in a sample. This incredible increase in detection limit allows for earlier analysis of samples and the better understanding of formulations.

 

SONICC is able to create 3D reconstructions of powders and tablets allowing for the analysis of spatial distributions of crystalline material.

 

Lower Quantitation of Crystallinity

 

SONICC enables quantitation of crystallinity at least 2 orders of magnitude lower than PXRD. The selectivity of SONICC to chiral crystals allows one to detect down to 0.01% crystalline material in a solid dispersion. Comparison of XRD to SONICC for a griseofulvin sample as a function of time cryo-milled is shown here.

 

X-Ray diffraction data (left) and relative SHG signal (center) for pure crystalline griseofulvin as a function of time cyro-milled. Log plot of percent crystallinity versus time cryo-milled for XRD and SHG (right)

Image credit: Wanpun, et al. Anal. Chem. 2011, 83 (12), 4745-4751)

 

Visualization of Spatial Distribution of Crystalline Material

 

SONICC is a microscopy technique that allows one to visualize the distribution of crystalline material in the sample. SONICC can penetrate 400 μm into a sample also allowing for 3-D imaging of powders or tablets.

 

SONICC images of powder dispersions with various amounts of crystalline griseofulvin spiked in. Each image is 2mm² and acquired in 500 ms.

 

 

To learn more about SONICC for API, please email info@formulatrix.com