The BET surface-area technique can accurately identify and quantify batch-to-batch variation in the processing of powders.
Different batches of the same APIs can exhibit different physical and mechanical properties.
The source of batch-to-batch variability of these APIs can be difficult to ascertain.
According to an article by Novartis Pharmaceutical, its researchers have discovered that BET surface area can help them determine batch-to-batch variability.
Novartis scientists used a Micromeritics ASAP 2020 Accelerated Surface Area and Porosity analyser to characterise different batches of API that exhibited different flow properties.
They found that the amorphous content of the batches varied.
From this information, they were able to conclude that the varying amorphous content of the batches was the source of the variability in flow behaviour.
These Novartis findings strongly support the BET surface-area test method as an important tool in the investigation of batch-to-batch variation and their overall development and production process.
Micromeritics manufactures a line of automated analytical laboratory instruments that measure the physical characteristics of powders and solids for fundamental research, product development, quality assurance and control, production and process-control applications, including nanoscience.
Physical characteristics determined include: particle size, surface area, pore volume, pore size and pore-size distribution, absolute density, envelope density, bulk density, catalytic activity and active surface area.
Micromeritics Pharmaceutical Services (MPS) is a DEA-licensed, FDA-registered, cGMP/GLP-compliant contract analytical laboratory.
