Preservative efficacy testing (PET) of pharmaceuticals according to Ph. Eur. 5.1.3

Microbiological test package for pharmaceutical or cosmetic products and ingredients according to European Pharmacopoeia methods Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13. The most recent edition of the pharmacopoeia is followed. The following parameters can be included in the analysis package: Total aerobic microbial count (TAMC) according to Ph. Eur. 2.6.12, Total combined yeasts and moulds count (TYMC) according to Ph. Eur. 2.6.12, Tests for specified microorganisms according to Ph. Eur. 2.6.13, including e.g., S. aureus, P. aeruginosa, E. coli, and C. albicans. These analyses are commonly conducted on the finished product and/or starting materials and intermediates as part of pharmaceutical batch release testing.

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.

We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN 14683 standard. The tests included in the packages are required to label face masks with the CE marking. Medical face masks are divided into Types I and II according to their bacterial filtration efficiency. Type I masks are not intended for healthcare professionals, but for the public to prevent the spread of infectious diseases. Type II masks are further classified based on whether they are splash-resistant (Type IIR) or not (Type II). To comply with the European Standard EN 14683, Type II face masks must undergo the following quality tests: Bacterial filtration efficiency (BFE) - The ability of the face mask to filter the bacterium Staphylococcus aureus. The BFE is expressed as the percentage of colony-forming units (cfu) that have passed via aerosol through the facemask. If a face mask consists of two or more areas with different characteristics, these areas will be tested separately., Breathability (Differential pressure) - The amount of differential pressure required to draw air through a measured surface area at a constant flow rate., Microbial cleanliness (Bioburden) - The measurement of colony forming units per gram as per EN ISO 11737-1., Biocompatibility - The medical face mask manufacturer shall complete a biocompatibility evaluation according to ISO 10993-1 as a surface device with limited contact. The applicable toxicology testing regimen shall also be determined.. In addition to the above, Type IIR masks require the following test: Splash resistance - Performed according to ISO 22609, this test determines the ability of a face mask to resist penetration of splashes of liquid at different pressures.. The lower displayed price applies to the Type II mask test package, while the higher price also includes the splash resistance test required for Type IIR masks.

In air jet sieve analysis, a rotating jet of air disperses a powder sample on a sieve, causing fine particles to pass through the mesh while oversize particles are retained. The mass percentage of particles retained on the sieve is determined and reported. The measurement can be repeated using multiple sieves of different mesh sizes to determine the particle size distribution characteristics of the sample. Several mesh sizes down to 20 µm are available. The displayed price applies to non-GMP analysis of a single sample with one sieve. The analysis is also available under GMP and ISO 17025 accreditation, and an expedited turnaround time can be arranged upon request. Please contact our experts for a quote.

This testing package combines several synchrotron-based X-ray techniques to characterize intravenous ferric carboxymaltose products in accordance with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, which require the manufacturer to demonstrate that the tested product is of similar quality to an already approved reference product. Synchrotron measurements are used instead of conventional ones to ensure the necessary signal-to-noise ratio and resolution for highly disordered and/or nanoscale materials. The following analyses are included: Determination of iron species' oxidation states (e.g., Fe3+), coordination geometry, electronic structure, and qualitative identification of the local chemical environment with XANES (X-ray absorption near edge structure)., Quantitative local atomic structure, including neighbouring atom types, coordination numbers, bond distances, and structural disorder with EXAFS (extended X-ray absorption fine structure)., Identification of the precise polymorphic form of the core (e.g., akaganeite-type FeOOH) and calculation of unit cell parameters and crystallite dimensions with HR-XRPD (high-resolution X-ray powder diffraction) & PDF (pair distribution function)., Measurement of distinct length-scale regimes to distinguish the crystalline inner core size from the total particle dimensions, with possible sensitivity to the amorphous surface layer with SAXS (small-angle X-ray scattering) & PDF., Evaluation of the overall shape of nanoparticles with SAXS to confirm whether the scattering bodies are compact, elongated, or branched.. The results are compiled into a single test report that correlates findings across the different techniques and compares them with the expected reference parameters.

Laboratory analysis for determining the total number of colony-forming units of bacteria, bacterial spres count as well as yeast and molds in dry market pulp, paper, and paperboard after disintegration. NOTE: Please note that while preparing the samples for shipping, please use aluminum foil/ envelopes/ self-closing plastic bags to protect the samples. Samples can be wrapped as such in aluminum foil, in ready-to-use sterile envelopes, or in self-closing bags, which are commercially available.

Standard ISO 22196 outlines a method for evaluating the antibacterial activity of plastics and other non-porous surfaces. The procedure involves inoculating the sample with a specified concentration of bacteria, typically Staphylococcus aureus or Escherichia coli, and incubating it under controlled conditions. After incubation, the number of viable bacteria on the test surface is compared to that on an untreated control surface. The difference is quantified as a logarithmic reduction, indicating the level of antibacterial activity. This method is widely recognized as reproducible and consistent, making it a reliable tool for assessing the efficacy of antibacterial treatments in industries such as healthcare, packaging, and consumer products. The lower end of the price range applies to testing with one bacterial strain, while the higher end includes analyses with both S. aureus and E. coli.

Shelf life refers to the time between the production date and the "best before" or "use by" date of a product. In the EU, the date of minimum durability is mandatory food information for almost all packaged foods, supplements, and feed products. During the product's shelf life, when stored according to instructions, the product should: Not pose a microbiological hazard to the consumer. Microbiological risks are usually more prevalent in perishable products, such as raw meat and dairy, but must also be accounted for with more stable products with a longer shelf life. , Not pose a chemical hazard to the consumer. Certain toxins may accumulate in the product due to microbiological activity. It is also possible that the packaging material is not fully compatible with the contents, causing contaminants to leach into the food or feed., Retain all relevant characteristics, such as nutritional value, consistency, and flavor. . There are various approaches to assessing the stability of food products over their intended shelf life: Sensory analysis can be used to assess the retention of sensory properties, such as flavor and odor., Nutritional analyses, measurement of water activity, and pH give information about changes in composition. They can also be used to assess microbiological stability and risks., Nutrient level monitoring is necessary for products containing vitamins and other nutrients to ensure that nutrient levels are maintained throughout the shelf life., Fat oxidation parameters, such as peroxide, p-Anisidine, and TOTOX value, can be used to assess the oxidative stability of fat-containing foods. Fat oxidation parameters can, in some cases, also explain a downward trend in sensory quality.. Shelf life studies can be conducted in real-time using the storage conditions described in the packaging. Alternatively, accelerated studies in elevated temperature and/or relative humidity can be performed to approximate the shelf life within a shorter time frame. In addition to the best-before or use-by date, the period after opening can also be determined. Every shelf life study is unique, and the testing conditions, duration, and analyzed parameters are chosen based on product characteristics and related risks. For more information and a quote tailored to your product, please contact us through the form below.

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