Jordan Saavalainen

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 or USP <785> 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.

Chemical characterization according to the ISO 10993-18 standard is performed to identify the constituents of a medical device and to estimate and control the risks associated with its chemical composition. The test is a key part of assessing the biocompatibility of medical devices. Chemical characterization includes the estimation of substances released under simulated or exaggerated laboratory conditions (extractables) or the detection of actually released substances (leachables) by the medical device during clinical use. Applicable methods may include HS-GC (volatile organic compounds), GC-MS (semi-volatile organic compounds), LC-MS (non-volatile organic compounds), and ICP-MS (inorganic elements). Suitable tests, solvents, and analysis methods are chosen according to the device's composition, intended contact time, and site. Any chemicals detected above concentrations established to be safe require further evaluation, typically through a toxicological risk assessment (ISO 10993-17). We provide a range of chemical characterization tests customized to the product, the intended market area (MDR, FDA), and quality requirements (GLP, accreditation). The starting price is based on the chemical characterization of volatile organic compounds (GLP, FDA).

The biocompatibility of medical devices with breathing gas pathways is generally assessed according to ISO 18562 standards. Measurlabs offers tests according to this standard family, including the following: ISO 18562-2: Tests for emissions of particulate matter (PM), ISO 18562-3: Tests for emissions of volatile organic substances (VOS), ISO 18562-4: Tests for condensate volume and leachables from condensate. Our experts are happy to help with any questions related to the tests and prepare a quote for you. Describe your testing needs using the form below, and we will get back to you shortly.