Particle size distribution (PSD) by laser light diffraction according to Ph. Eur. 2.9.31

This analysis provides quantitative information about the crystalline and amorphous phases within your sample using high-resolution synchrotron X-ray diffraction (XRD). A standard analysis includes: Quantification of crystalline phases as weight percentages, Quantification of the total amorphous content, High-resolution powder diffraction data and the resulting diffractogram, A comprehensive test report detailing the findings. For more advanced needs, we also offer total scattering/pair distribution function (PDF) analysis to reveal the local atomic structure in amorphous or nano-structured materials. Do not hesitate to ask for a quote.

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.

Quantification of subvisible particulate matter in injectable and parenteral solutions according to USP <788> or the harmonized method Ph. Eur. 2.9.19. Testing is commonly performed as part of batch release and compliance verification against particle count limits. We offer both methods specified in USP <788> and Ph. Eur. 2.9.19: Method 1: Light obscuration particle count, Method 2: Microscopic particle count. Method 1 is generally preferred unless the sample is not suited to it, for example, because of high viscosity, opacity, or a tendency to form gas bubbles. In some cases, it may be necessary to perform both tests (e.g., when Method 1 results are borderline). Results are reported as particle counts by size range per container or per specified sampling unit. A comparison against the applicable pharmacopoeial limits or customer-defined specifications is also provided.

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.

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.

Analysis of the specific surface area of porous, solid materials according to the BET (Brunauer–Emmett–Teller) theory. Analysis can be performed with N2 or Kr gases, depending on the expected surface area of the material. BET curve and the specific surface area (in m2/g) are reported. The required sample amount depends on the expected surface area. As a rule of thumb, at least 5 m2 of surface area should be available for measurement. The following gas adsorption devices are used for this measurement: Micromeritics Gemini VII 2390, Micromeritics ASAP 2020, Micromeritics TriStar II 3020, Anton Paar Nova 800.

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..

Determination of dissolved hormones and pharmaceuticals in wastewater by UPLC-MS/MS according to ISO 21676, or by an in-house LC method. Samples must be stored and shipped below 8°C after sampling to preserve analyte stability. The analysis covers more than 150 pharmaceutical and hormone compounds, all with a typical LOQ of 0.1 µg/l. Examples include: Estriol, Ethinyl estradiol, 17β-Estradiol, Estrone, Sulfadiazine, Fenbendazole, Norfloxacin, Ofloxacin, Ciprofloxacin. The full list of analytes is available upon request. The method is commonly applied to monitor wastewater treatment performance, assess environmental emissions of pharmaceutical residues, and support monitoring under EU water quality frameworks.