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| As of the FDA and the German authorities inspected and accepted GMP-Lab, we develop analytical methods, validate according to the current ICH-guidelines and are proficient in chemical and microbiological analytics for the determination of pharmaceutical products, active substances and excipients in the terms of the § 14 (4) AMG and in compliance with the GMP- guidelines.
Hereunto belong
- atomic absorption spectroscopy for element analysis
- analysis of refractive index
- density determination
- capillary electrophoresis
- dissolution testing with paddel-, bascet- und cylinder method and following determination of assay with HPLC, GC, UV etc.
- thin layer chromatography
- GC (FID, WLD, NPD) and GC-MS determination of assay and purity testing
- hardness testing of tablets with thickness, length and mass testing
- HPLC/UPLC (DAD, VWD, RID, FLD) and HPLC-MS-MS determination of assay and purity testing
- hygiene monitoring, with bacterial count of air and contact plates for surfaces
- ion chromatographic assay
- IR-spectroscopy
- microbiological testing for efficacy of antimicrobial preservation of non sterile pharmaceutical preparations
- testing of the microbiological qualitiy of non sterile pharmaceutical preparations
- microscopy
- determination of residual solvents with GC
- cleaning validation, analytics of rinse- and swab samples
- melting point testing
- heavy metal analytics
- heavy metals with ICP-MS, ICP-OES and AAS
- stability testing including storage of stability samples, handling in GMP-motored climate chambers
- titrations
- TOC-analysis of purified water
- UPLC assay and purity testing
- UV-absorption testing
- viscosity testing
- water content with Karl-Fischer titration
and many other methods.
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