Microbiological analysis of pharmaceuticals & cosmetics according to European Pharmacopoeia

Nondestructive 3D analysis of internal structures by X-ray computed tomography. The method visualizes voids, cracks, density, and phase differences within solid structures. The analysis is suitable for powdered materials, such as pharmaceutical and cosmetic ingredients, as well as bulk solids and parts, such as machine parts and wafers. The voxel size can go down to 60 nm. Please contact us for more information about the analysis options for different materials and material dimensions. Some devices available for the analysis are as follows: Bruker SkyScan 1272 CMOS, Bruker SkyScan 2214 CMOS, Zeiss Xradia 515 Versa.

Test of 1 bottle at 20 °C with Malvern Spraytec to characterize particle sizes between 0.1 µm and 900 µm with a standard distance between the nozzle and the laser beam. The results are reported for 3 repeat shots. Particle size distribution histograms, percent finers (Dv10, Dv50, Dv90), and % of particles smaller than 5 µm, 10 µm, and 50 µm are reported. Providing two 100% charge spray bottles per analysis is recommended for aerosols. Contact us for a quote and more information on analyses under nonstandard conditions.

High-resolution imaging with a transmission electron microscope (TEM) for capturing morphology, crystal structure, and defects at nanometer resolution. Typically, several images with varying magnifications are taken to get a good overview of the sample. We also provide FIB preparation to analyze the cross-section of any specific site of interest, including microelectronic stacks and loose powders. HR-TEM for atomic-level resolution, STEM for high-contrast images, and cryo-TEM for sensitive samples are also possible. For complementary compositional analysis along with the structural data, TEM-EDX and TEM-EELS elemental analyses are available. Contact us for more details.

Determination of particle size distribution (PSD) by dynamic light scattering (DLS). Analysis can be done from dispersions or solids that can be dispersed in water or organic solvents. The method is suitable for particle sizes from 0.4 nm to 10 µm.

Phase identification and quantification (Rietveld analysis) of a crystalline powder material using X-ray diffraction (XRD). The analysis can also provide unit cell dimensions. The analysis is only suitable for materials with at least one crystalline phase. The quantification accuracy is roughly 0.1 %, depending on the sample matrix and the phase in question. The available temperature range for XRD measurements is 25-1100 °C and the crystallinity can be studied as a function of temperatures. The measurements can be done under a normal atmosphere, inert gas, or vacuum. Please contact our experts to discuss the available temperature and atmosphere combinations. Please mention which crystalline phases your material contains and which ones are you interested in quantifying when requesting testing. However, the method can be applied to unknown phases as well. Either a tabletop or a synchrotron XRD can be used to perform the measurements.

Imaging of the sample using scanning electron microscopy (SEM). Typically, several images are taken with varying magnifications to get a good overview of the sample. Non-conductive samples can be prepared with a metallic coating to allow imaging. For cross-section measurement, additional preparation might be needed: FIB, BIB, or freeze fracturing. Cryo preparation is available for biological materials and other sensitive sample types. If compositional analysis is also needed, please see the SEM-EDX measurement. We also offer high-temperature SEM analyses at temperatures up to 1400 °C. Do not hesitate to ask for a quote.

Imaging of the sample using a scanning electron microscope (SEM) with energy-dispersive X-ray spectroscopy (EDX or EDS). Typically, several images are taken with varying magnifications to get a good overview of the sample. An EDX mapping, line scan, or point measurement is collected to measure the sample composition (elemental at.% or wt.%). Non-conductive samples can be prepared with a metallic coating. For cross-section measurement, additional preparation might be needed: FIB, BIB, or freeze fracturing.

Qualitative or comparative analysis of crystalline powders using X-ray diffraction (XRD). The analysis is only suitable for materials with at least one crystalline phase.

UPLC-MS/MS analysis for determining the melatonin content in dietary supplements. According to Regulation (EU) No 432/2012, melatonin supplements may be marketed with the following health claims: "Melatonin contributes to the alleviation of subjective feelings of jet lag." The claim can be used if the product contains at least 0.5 mg of melatonin per portion., "Melatonin contributes to the reduction of time taken to fall asleep." The claim can be used if the product contains at least 1 mg of melatonin per portion..

Benzoic and sorbic acids can be used as preservatives in various foods. Regulation (EC) No 1333/2008 regulates the foods in which benzoic and sorbic acid can be used as additives and specifies the maximum levels allowed. This HPLC-UV method can be used to quantify amounts of benzoic and sorbic acids or corresponding sodium and potassium salts.