Pharmaceutical, Medical Products
We are familiar with pharmaceutical testing requirements. At present, 90% of our testing orders come from the Pharma industry.
We carry out pharmaceutical analysis tests according to national or international pharmacopoeias, such as DAB, DAC, HAB, Ph. Eur., USP, BP, JP and customer specifications, such as approval documents. Many years of analytical practice result in high levels of expertise in this area.
Our GMP conformity with pharmaceutical chemical analysis, pharmaceutical and technological analysis, and chromatographic analysis is regularly inspected and certified by the German GMP authorities.
Additionally, we are registered with the FDA.
For cytostatic samples, we have created a high-potent lab area. There, these substances are safely handled and tested by trained personnel.
We also analyse narcotic samples when approved by the German Federal Office for Medicines and Medical Products, Federal Opium Agency.
We offer the following analytical tests of raw materials, semi-finished goods, finished medical products and medical devices:
Analytic Lab Services
- Methods of physics and physical chemistry
- Osmolality, TOC, viscosity, and more
- Identification reactions
- Ions and functional groups, DC, and more
- Limit tests
- Heavy metals, sulphated ash, residual solvents, ethylene oxide and dioxane residues, fatty acid composition, and the more
- Characteristic key values, complexometric titrations, Karl Fischer method, Kjeldahl method, oxidizing substances, and more
- Methods of pharmacognosy
- Sulfated ash, foreign substances, examination of essential oils, and more
- Methods of pharmaceutical technology
- Dissolution, uniformity, friability, sieve analysis, bulk density and tapped density, visible and invisible particles
Furthermore, we test for metals, vitamins, mycotoxins, residual solvents, and more
Climate storage according to ICH guidelines offered (25°C / 60% RH, 30°C / 65% RH, 40°C / 75% RH, 2° – 8°C, -20°C)
Thanks to our close cooperation with other Tentamus laboratories we can offer a wide range of different analysis.