Determination of the active substances of drugs is necessary to study pharmacokinetic parameters. Pharmacokinetic studies are required for preclinical studies (when animal biomaterial is studied), as well as in the early phases of clinical trials (Phase I, Phase II clinical trials), as well as for bioequivalence studies during registration of reproduced drugs (generics).
Quantitative analysis of low molecular weight drugs at Exacta Labs is performed by HPLC-MS/MS in compliance with the current regulatory requirements of the Eurasian Economic Union.
Liquid chromatography with mass spectrometric detection (HPLC-MS/MS) is one of the most popular methods in modern analytical chemistry. It offers the advantages of high precision and sensitivity.
Prior to analysis the samples are prepared in order to maximize the extraction of the test compound from the biological matrix (plasma, blood, urine, saliva). A liquid chromatograph separates the rest of the sample into individual components and a mass spectrometer transforms these components into charged particles, then selectively recognizes the compound and determines its quantity, and the software calculates the concentration. The results are carefully processed by a highly trained analytical chemist, who confirms the correctness of the analysis performed. The analyst then generates a table of concentrations and prepares a report on the study. Following the results of the work, the customer will be provided with the table of concentrations, the analytical report, as well as the necessary primary data.
Pharmacokinetic and statistical parameters such as Cmax and AUC of the drug are calculated based on the results of the analysis.
In the case of an unstable active drug compound, the Exacta Labs bioanalytical laboratory has the option of working under yellow light, under cooling conditions - using an ice bath as well as selecting stabilizers.
For development and validation of methods for particularly difficult projects (very low sensitivity, endogenous compounds, unstable analytes), we have assembled a team of experts with highly qualified staff, with experience in development and validation of drug analysis methods for over 5 years.
Bioanalytical research requires expensive equipment and highly qualified staff. The group has 18 HPLC-MS/MS systems, 8 of which are in the Exacte Labs Bioanalytical Department. All mass spectrometers in the laboratory are manufactured by Sciex, and liquid chromatographs from leading world manufacturers Agilent, Shimadzu, Waters. Each system has redundant equipment, ample spare parts and an in-house service to ensure uninterrupted operation of the instruments.
Analysis of the drug concentrations in biological samples at the Exacte Labs analytical center is performed in accordance with Annex 6 to the Rules for investigations of bioequivalence studies of drugs within the EAEC.
Exacte Labs quality management system is certified for compliance with ISO 9001:2015, GLP principles of good laboratory practice, as well as for compliance with the international standard ISO 17025 (in the Russian accreditation system GOST ISO/IEC 17025).
More than 300 developed and validated methods (plasma, whole blood, serum, urine) for which we can offer optimal analysis terms.
Provision of additional services - ordering of standards, preparation of laboratory kits, calculation of pharmacokinetic and statistical parameters, as well as long-term deep-freezing storage of biological samples is possible.
Exacte Labs can develop a customized laboratory manual for the clinical part of the study and assemble protocol-specific kits for a biological sample. The manual describes all the necessary preparations for sample preparation before sending it to the bioanalytical laboratory.
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