Chemical Analysis
We perform a wide variety of analytical studies in connection with physico-chemical characterisation, quality control and stability of active principles, drugs and raw materials generally.
A wide experience in analysis and a deep knowledge of the pharmaceutical regulatory environment enable KYMOS to offer complete analytical services of all of the stages of a research, including development and marketing of a pharmaceutical product, in accordance with the sector’s quality standards (BPL and GMP), adapted to the customers’ specific needs.
Outstanding among the analytical studies performed by us are development and validation of analytical methods for determining content, related substances, residual solvents, dissolution assays, preservers, etc., that are necessary to carry out raw material and finished product quality control, as well as development and validation of stability-indicating analytical methods.
We offer the complete performance of stability studies, from storage in own climatic chambers through control of all the critical parameters as per the prevailing regulations. We also carry out photostability studies in ICH conditions, and stress testing.
Being certified regarding GMP compliance entitles us to perform quality control analyses of products destined to be commercialised or used in clinical research.
Finally, we can offer a complete range of services based on the NIR (Near Infrared Spectroscopy) technology, including raw material and excipient identification, quantification of the majority composants of finished products, and validation of identification and quantification methods – we hold ourselves accountable for both the experimental performance of the studies and their transferral to the customer, with previous coverage of their training requirements.
