Produits pour la caractérisation des particules
Greetings from your friends at HORIBA Instruments!
Our October newsletter focuses on the pharmaceutical industry where HORIBA offers many technologies successfully applied to both R&D and regular QC requirements. These analytical tools will be on display at the AAPS meeting in San Diego, November 12-14, or you can follow the links to the pharmaceutical industry page on our website for more information.
Laser Diffraction Method Development
A structured approach to method development will lead to precise, robust results when using the LA-950 laser diffraction analyzer. Developing new methods for suspensions involves sampling, the choice of surfactants and dispersing media, the use of ultrasound and sampler settings, and sample/system interactions associated with refractive index and concentration. Dry method development substitutes choice of air pressure for ultrasound as the route to add energy to disperse the sample.
The guidelines provided in our method development application notes assist customers with practical advice on structured approach to method development will lead to precise, robust results to create thorough standard operating procedures for unknown samples.
Application note on Wet Method Development (You need to be logged in).
Application note on Dry Method Development (You need to be logged in).
The USP <429> Test "Light Diffraction Measurement for Particle Size"
The new USP <429> test should also be considered by anyone creating diffraction methods in the pharmaceutical industry. This monograph sets guidelines for the reproducibility of three replicate measurements based on the coefficient of variation (COV, the standard deviation/mean). The COV at the D50 must be < 5% and less than 15% at the D10 and D90. These values can be doubled for samples where the D50 is < 10 µm. These calculations are being added to the LA-950 software, along with an automatic system verification routine using a polydisperse standard as described in USP <429>.
Application note on Utilizing USP <429> (You need to be logged in).
Digital Image Analysis
The pharmaceutical industry creates many particle based products where the shape is an important physical characteristic requiring quantification. The Camsizer digital image analyzer provides particle size and shape information for samples such as globules and engineered particles with layers of coatings. This technique could also be useful for characterizing the size and shape of excipients such as sugar spheres.
Application note on the Determination of Roundness of Globules in the Pharmaceutical Industry (You need to be logged in).
Raman Mapping
The ARAMIS from the HORIBA Jobin Yvon Raman Division provides information on particle properties including size, shape and chemical identification within final products such as tablets. This data is useful for investigating content uniformity, polymorphism, coating thicknesses, component mapping, and differentiation between amorphous and crystalline phases.
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