Refractometers for Powder – Particle Size Analysis
Refractometers to measure the RI for Powder Size Analysis – In May 2015 Rudolph Research Analytical released additional capabilities for all pharmaceutical level refractometers. The J257, J357, and J457 refractometers come standard with a method for measuring the RI or refractive index of powders as required by a particle size analyzer and developed by Hans Saveyn and his collaborators.
Particle size analysis is important in developing and producing drugs as particle size has a direct impact on a drug’s final product performance. Particle size has a direct relationship to pharmaceutical product dissolution rates, absorption rates and final product uniformity. Decreasing particle size is a help when working with non-water soluble chemicals. Thus particle size measurement techniques and methods must be accurate and traceable in both the drug development stage and during production manufacturing to ensure quality control.
Rudolph Research Analytical is a world leader in refractometers designed for pharmaceutical applications. While there are many companies making refractometers for measuring soft drink, orange juice and other food products there are very few other instruments that have been designed with pharmaceutical needs in mind.
Rudolph Refractometers used in Pharmaceutical Powder and Particle Size Analysis
In particular the J257/J357/J457 offer;
- Wide range from 1.26 to 1.70 meaning the instruments can measure every material in the USP/EP.
- 21 CFR Part 11 data storage system that is integrated into the instrument, no external software is needed.
- Accuracy levels required in pharmaceutical labs to Index ±0.00002 RI.
- SmartMeasure system that monitors correct sample loading and cleaning.
Adding this capability gives pharmaceutical laboratory considerable advantages. While it is possible to find RI measurements of some materials on the web there are some issues related to taking this approach. Using the actual measured value (rather than the nominal published value) eliminates many possible sources of error. The second issue is you are relying on an unverified source in a procedure where all measurements results need to be traceable back to an operator and method – a pharmaceutical company cannot just write down a number found on the web. All the features that make the J Series the instrument of choice for pharmaceutical liquids and waxes are now added to powders.
This measurement can also be done at the same conditions that the particle size analyzer is set to.
- The refractometer can be chosen with a wavelength to match the particle size analyzer.
- Refractive index is very temperature sensitive and the J Series refractometer has variable built in temperature control. It can be set to measure at the same temperature the particle size analyzer operates at.
For additional study, reference the paper:
Determination of the Refractive Index of Water-dispersible Granules for Use in Laser Diffraction Experiments by: Hans Saveyn, Dries Mermuys, Olivier Thas, Paul van der Meeren
Modern laser light scattering equipment can cover a very broad particle size range by using complex algorithms, such as the Mie theory. A disadvantage of this theory, however, is that it requires the knowledge of the refractive index of the particles, which is not straightforward for powdered organic substances. In this study, thiram, a common dithiocarbamate fungicide, was used as a model compound. In a first part, a method was elaborated to determine the refractive index, based on refractive index measurements of solutions of the compound of interest in a range of solvents. Two different extrapolation techniques were compared. Both techniques were validated by applying them to the determination of the refractive indices of poly(vinyl acetate) and poly(methyl methacrylate). Secondly, the influence of the refractive index value on the generated particle size distribution in the laser diffraction software was investigated. It was observed that widely different particle size distributions can be generated by the laser diffraction software for a single experimental data-set. Therefore, accurate refractive index information is required to obtain reliable particle size distribution results.
For more details contact Rudolph Research at email@example.com