Laboratory testing services

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.

Qualitative identification of chemical groups in solid samples by Attenuated total reflectance Fourier-transform infrared spectroscopy (ATR-FTIR). Results will be delivered as an FTIR spectrum. In addition, a comparison to an FTIR library will be provided. The method is not quantitative, but it can be used to identify the main chemical components of the sample.

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.

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. If compositional analysis is also needed, please see the SEM-EDX measurement.

Determination of osmolarity of liquid samples using a freezing point osmometer according to the European Pharmacopoeia method Ph. Eur 2.2.35. Osmolarity is defined as the number of osmols per liter of liquid, reflecting the total number of dissolved ionic and molecular substances present in the solution in molarity. The results of the analysis are reported in mOsm/L. NOTE: The total concentration of the solute in the product needs to be provided (expressed in g/mL), as this information is necessary for the calculation of osmolarity. Without this information, only the product's osmolality (mOsm/kg) can be determined. If the product is a powder, please provide instructions for the preparation of the solution. Analysis can also be performed under GMP - please ask us for an offer.

The osmolality of liquid samples is determined using a freezing point osmometer according to the Ph. Eur 2.2.35 method. Osmolality is the number of osmols per kilogram of liquid, and it reflects the total number of dissolved ionic and molecular compounds present in a kilogram of solution. The results of the analysis are reported in mOsm/kg. The analysis includes the determination of relative density, as the value is necessary to calculate osmolality. NOTE: If the product is in powder form, please provide instructions for preparing the solution. Analysis can also be performed under GMP - ask for an offer from our experts.

Imaging of the sample with transmission electron microscopy (TEM) and determination of the elemental composition of the sample using electron dispersive X-ray spectroscopy (EDX or EDS). Several images with varying magnifications are taken 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.%). For solid samples, the analysis often requires FIB preparation, which is priced separately. HR-TEM can also be provided. Contact us for more details about the analysis options.

Imaging of the sample with transmission electron microscope (TEM). Typically, several images with varying magnifications are taken to get a good overview of the sample. TEM allows nm-resolution images. Solid samples often require FIB preparation before analysis. HR-TEM can also be provided. 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.

Analysis to determine the concentrations of organic substances (pharmaceuticals and drug precursors) listed in the revised Urban Wastewater Treatment Directive (EU) 2024/3019. The analysis includes eight substances that can be very easily treated: Amisulprid (CAS: 71675-85-9), Carbamazepine (CAS: 298-46-4), Citalopram (CAS: 59729-33-8), Clarithromycin (CAS: 81103-11-9), Diclofenac (CAS: 15307-86-5), Hydrochlorothiazide (CAS: 58-93-5), Metoprolol (CAS: 37350-58-6), Venlafaxine (CAS: 93413-69-5). And four substances that can be easily disposed of: Benzotriazole (CAS: 95-14-7), Candesartan (CAS: 139481-59-7), Irbesartan (CAS: 138402-11-6), Mixture of 4-Methylbenzotriazole (CAS No 29878-31-7) and 6-methyl-benzotriazole (CAS No 136-85-6). This method is suitable for wastewater samples with low total solids and dissolved solids content. Please check the suitability of the sample matrix with the testing expert when requesting an offer.

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 the concentrations of Co, Si, P, S, B, and Na in solid chemicals. This method is meant for chemicals like Co(NO3)2. The results include the concentration of the main component (Co) and the concentrations of selected impurities.

British Pharmacopoeia standard measurement for alginate raft-forming oral suspension's raft strength.

The analysis determines the concentration of substances listed in Annex I to Directive (EU) 2024/3019 on urban wastewater treatment. Substances that can be very easily treated: Amisulprid (CAS: 71675-85-9), Carbamazepine (CAS: 298-46-4), Citalopram (CAS: 59729-33-8), Clarithromycin (CAS: 81103-11-9), Diclofenac (CAS: 15307-86-5), Hydrochlorothiazide (CAS: 58-93-5), Metoprolol (CAS: 37350-58-6), Venlafaxine (CAS: 93413-69-5). Substances that can be easily disposed of: Benzotriazole (CAS: 95-14-7), Candesartan (CAS: 139481-59-7), Irbesartan (CAS: 138402-11-6), 4-Methylbenzotriazole (CAS No 29878-31-7), 5-methyl-benzotriazole (CAS No 136-85-6), The sum of 4-Methylbenzotriazole & 5-methyl-benzotriazole can be reported if requested. This analysis is intended for untreated wastewater. We also offer an analysis with the same target analytes for treated wastewater to determine how effectively the substances are removed during the treatment process. Read more about the testing requirements imposed by the new Urban Wastewater Treatment Directive here.

Chemical components of a solid sample material are identified using Raman spectroscopy. The analysis is suitable for inorganic and organic samples, excluding metals and alloys.

The ICP-MS technique provides information on the concentrations of metals in a sample. The measurement includes the following elements: Na, Mg, K, Ca, Li, Be, B, Al, Si, P, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Ga, As, Se, Rb, Sr, Zr, Nb, Mo, Ag, Cd, In, Sn, Sb, Te, Cs, Ba, Hf, Hg, Tl, Pb, Bi, U. In the results, the elemental concentrations are expressed in units mg/kg.

Nondestructive 3D analysis of internal structures by X-ray computed tomography. The method visualizes voids, cracks, density, and phase differences within solid structures. The method is most suitable for powdered materials, such as pharmaceutical and cosmetic ingredients. The resolution can go down to 2-3 µm for powders. Please contact us for more information about the analysis options for different materials and material dimensions.

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.

Microbiological test package for cosmetic products according to European Pharmacopoeia methods EP 2.6.12 and EP 2.6.13. The most recent edition of the pharmacopoeia is followed. The following parameters are included in the analysis: TAMC according to EP 2.6.12, TYMC according to EP 2.6.12, S. aureus according to EP 2.6.13, P. aeruginosa according to EP 2.6.13, E. coli according to EP 2.6.13, C. albicans according to EP 2.6.13.

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.

Nitrosamines are organic compounds formed by a nitrosating reaction between certain amines and nitrosating agents in acidic conditions. While they are not intentionally added to products, nitrosamines may end up in pharmaceuticals and cosmetics as impurities when manufacturing or storage conditions are conducive to their formation. As many nitrosamines are highly potent carcinogens, the European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA) require pharmaceutical companies to assess the risk of nitrosamine impurity presence in pharmaceutical products, including Active Pharmaceutical Ingredients (APIs) and finished products. An updated list of maximum acceptable intake (AI) levels for known nitrosamine impurities to be monitored in Europe can be found in Appendix 1 to EMA's latest guidance document. For US rules, see the FDA's list of recommended AI limits. We can provide nitrosamine testing for various products and matrices. The displayed price example is for a routine analysis (non-GMP) of one sample including screening of the following nitrosamines: NDMA (N-Nitrosodimethylamine), NMEA (N-Nitrosomethylethylamine), NPYR (N-Nitrosopyrrolidine), NDEA (N-Nitrosodiethylamine), NPIP (N-Nitrosopiperidine), NMOR (N-Nitrosomorpholine), NDPA (N-Nitrosodi-n-propylamine), NDELA (N-Nitrosodiethanolamine), NDIPLA/NBHPA (N-Nitrosodiisopropanolamine). New samples/products might need a feasibility study before routine testing. Please ask for a quote for the feasibility study and GMP analyses. We can also offer custom nitrosamine test packages tailored to your needs, especially for large sample volumes. Please ask for a quote for your samples!

Hot-stage microscopy (HSM) analysis enables the direct visualization of materials under controlled temperature conditions. Capabilities include: Examining compound morphology and particle characteristics., Observing solid-solid transformations, melting/liquefaction, solidification, sublimation, and evaporation., Monitoring how different compounds interact, dissolve, or react with each other., Tracking crystal growth and growth rates., Utilizing the Kofler mixed fusion method for salt/co-crystal screening., Observing oxidation and other chemical reactions as they occur under heat.. The results will include microscope pictures and video showing the transitions during heating. Measurement specifications: Temperature range: 25 °C to 375 °C, Humidity control: 5–90% RH. Instrument details: The instrument set-up comprises a heating stage (hot stage) with a sample holder, coupled with a polarized-light microscope and a system that allows temperature measurements and video/picture recording.

Raman spectroscopy is a non-destructive chemical analysis technique used for the identification of chemical components in a sample. This analysis is suitable for inorganic and organic liquid samples.

Determination of total sugar content, expressed as glucose, of food and feed with the Luff–Schroorl titration method.

We offer extractables and leachables (E&L) testing according to USP <1663> and USP <1664> to identify and quantify potential contaminants that could migrate from pharmaceutical packaging systems into the drug product. Extractables are organic and inorganic chemicals released from pharmaceutical packaging into an extraction solvent under laboratory conditions. The specific testing conditions (e.g., solvents, temperature) are chosen to simulate potential stresses on the packaging and differ depending on the extraction study's purpose. Leachables are organic and inorganic chemical compounds that migrate from pharmaceutical packaging materials, components, or systems into the drug product under simulated use conditions. These conditions are tailored to represent the drug product's shelf life, storage, and administration, enabling a realistic assessment of potential patient exposure. Examples of analytical techniques used to characterize potential contaminants include: HS-GC for volatile organic compounds., GC-MS for semi-volatile organic compounds., LC-MS for non-volatile organic compounds., ICP-MS for inorganic elements (metals).. E&L tests are always customized to the specific product that is studied. Contact our experts using the form below to get a quote for your material.

Analysis of gaseous samples using Raman spectroscopy.

Determination of reducing sugar content, expressed as glucose, from food and feed with the Luff–Schoorl titration method.