Pharmacopeia tests

We test raw materials and finished products according to the current pharmacopeias (Ph. Eur., USP, DAB, and others) to ensure the required pharmaceutical quality. Monographed raw materials are tested for identity, content, and purity. The testing of finished medicinal products typically includes the analysis of the following quality characteristics:

Identitye.g.:– IR spectroscopy
– UV-Vis spectroscopy
– Identity reactions (color and precipitation reactions)
Active substance contente.g.:– Titrations
– Chromatographic determinations (by HPLC or GC)
Purity e.g.:– Quantification of residual solvents by GC-FID
– Residual moisture determination by Karl Fischer titration
– Quantification of heavy metals
Physical tests e.g.:– Disintegration of tablets and capsules
– Softening time of lipophilic suppositories
– Uniformity of mass