We have extensive experience performing analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples. The most suitable method is used, according to customer specifications or the relevant Pharmacopoeias description (EP, USP, BP, JP). If non-compendial methods need to be used, we develop and validate the method from scratch or transfer the method from the manufacturer.
Physical-chemical Tests:
General Identification Tests (IR, TLC, HPLC)
Assay (UV/Vis, IR, AAS, titration, HPLC by using multiple detectors, UPLC, GC, LC-MS) and dosage uniformity
Impurities identification (HPLC, LC-MS)
Impurities determinations: degradation products, process and drug related impurities