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.

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!

ASTM F1980 establishes a standardized approach for accelerated aging of medical device sterile barrier systems (SBS), either with or without devices. Accelerated aging studies help manufacturers assess the shelf life of the product more rapidly than real-time aging studies. The results may be used as a preliminary indication of the product’s stability and packaging integrity until real-time aging results become available. This approach aligns with regulatory expectations, including FDA guidance (21 CFR - Process Validation) and ISO 11607-1. In accelerated aging studies, materials are exposed to elevated temperatures for a shorter period, simulating the effects of real-time aging. Based on the results, manufacturers can estimate how long the packaging will maintain its protective properties under real-world storage and transportation conditions. Product stability can be evaluated both upon completion and throughout the aging process using various methods. The assessed properties are selected based on the manufacturer’s specific requirements and regulatory considerations, and they may include the following: Sterility, Mechanical performance (e.g., shear, tensile, and compression strength), Chemical properties (e.g., product degradation). Measurlabs can provide accelerated and real-time aging in parallel. We can also help with stability and integrity testing during and after the aging period. Do not hesitate to contact us for a custom quote tailored to your project.

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.