Deep knowledge and understanding on particle size and shape analysis by “Laser Diffraction (LD), Optical and Electron Microscopy and Dynamic Light Scattering (DLS)” techniques are complemented by a vast experience to characterize any kind of material such as APIs (raw materials), product intermediates and final formulations. This contract analysis unit is fully GMP compliant for the characterization of APIs.
Our highly qualified team make use of our vast expertise and instruments for Particle Size Distribution (PSD) determination to provide the following analytical services:
We are also experts in Particle Morphology characterization. We make use of an “Automated Optical Microscope” and “Image Analysis” to fully characterize size and shape parameters of particulate matter and provide the following services:
Our services also focus on the characterization of nanoparticles. We determine Nanoparticle Size and Z-Potential of colloidal suspensions by “Dynamic Light Scattering” and “Laser Doppler Micro-Electrophoresis”, respectively. We can complement these techniques by the determination of Nanoparticle Size Distribution and concentration by “Nanoparticle Tracking Analysis”.
Our package of services related to solid state and liquid colloidal/suspension formulations analysis is complemented by:
Nanomol Technologies works with high-quality standards, having implemented a Good Manufacturing Practices (GMP) Quality System. Nanomol Technologies has been already qualified by its costumers as cGMP contract analysis service for the characterization of APIs. This successful process matches the next objective of obtaining the GMP certification for particle analysis of finished and intermediate pharmaceuticals, applying for both human and veterinary medicinal products. By these quality policies, Nanomol Technologies contract analysis unit:
All staff in Nanomol laboratories is trained to work properly and in accordance with the GMP requirements with the objective of obtaining fully reliable and traceable results from robust analytical methodologies. The company has a Quality Assurance Department which is in charge of the maintenance and improvement of the quality in the complete analysis process, from the reception of the samples to their treatment as waste.
Particle size is the most important physical property of particulate samples. Particle size has a direct influence on material properties such as reactivity or dissolution rate, stability in suspension, efficacy of delivery in drug delivery systems, texture and feel of food ingredients, appearance in powder coatings and inks, etc.
Measuring particle size and understanding how it affects your products and processes can be critical to the success of many manufacturing businesses, therefore these parameters can become Critical Quality Attributes (CQAs).
We are experts on the use of the world’s most widely used particle size analysers, Malvern Mastersizer Laser Diffraction instrument. We are equipped by the latest generation version of this instrument, Mastersizer 3000, a particle size analyser that delivers accurate particle size distributions for both wet and dry dispersions, over the nanometer to millimeter particle size ranges.
As well as particle size, the shape of constituent particles can also have a significant impact on the performance or processing of particulate materials. Particle shape in addition to particle size measurements are extremely useful in order to gain a better understanding of any particle-based product (pharmaceutical actives, drug delivery systems, ceramic filters, food ingredients).
In Nanomol Technologies we are also equipped by Malvern Morphologi G3S, an automated image analysis tool being a high-resolution direct technique for characterizing particles from around 0.5 micron up to several millimetres in size. Individual particle images are captured from dispersed samples and analysed to determine their particle size, particle shape and other physical properties. Statistically representative distributions of parameters can be constructed by measuring tens to hundreds of thousands of particles per measurement. These size and shape morphological parameters are Circle equivalent (CE) diameter, length, width, perimeter, area, maximal distance, sphere equivalent (SE) volume, fiber total length, fiber width, aspect ratio, circularity, convexity, elongation, high sensitivity (HS) circularity and solidity.
We are experts and advanced users of nanoparticles characterization tools for analysing: