Analytical chemistry services

Selvita has assembled a unique team of eminent scientists and highly skilled professionals with broad experience from pharmaceutical industry. At Selvita, we present client-oriented attitude with the aim of delivering top quality, quick and cost effective services.

Development validation and verification of analytical methods

Our services cover analytical as well as bioanalytical method development and validation. In addition, we perform pharmacopeial methods verification. We have expertise in using instrumental analytical methods including HPLC and LC/MS. Method development, validation and verification is in compliance with ICH guidelines as well as with EMEA and FDA regulations. To provide customers with flexibility we offer the possibility of working according to our own Standard Operating Procedures or following protocols supplied by customers. After validation exercise is completed, the customer receives a validation protocol and a report. We also offer assistance during method implementation and transfer as well as full support during revalidation.

Evaluation of API suppliers

Selvita supports our customers during the process of evaluation of active pharmaceutical ingredient (API) suppliers. Our laboratory provides a package of analytical services for qualitative assessment of APIs.

Cleaning validation

Our analytical and R&D scientists develop and validate methods suitable for trace analysis of active pharmaceutical ingredients. We use HPLC methods with UV-VIS detection and employ an innovative approach that combines HPLC and mass spectrometry (LC/MS). The latter technique offers superior sensitivity as compared to that with UV-VIS detection as well as high specificity.

In addition, BioCentrum develops methods for the recovery of APIs from various product contact materials used in production plants, i.e. steel, glass and a range of seal materials. We also provide research on swab sample storage time and conditions varying parameters such as storage lighting and temperature.

Detection of residual solvents

According to EMEA and FDA guidelines residual solvents are a specific group of impurities. Due to the lack of therapeutic effect, solvents present in the API should be reduced to the lowest level possible, that is defined in the relevant guidelines. Selvita offers API analysis and determination of the content and concentration of residual solvents by means of GC/MS.

Evaluation of pharmaceutical availability

Drug pharmaceutical availability evaluation is extremely important not only at the stage of drug quality control but is also an indispensable research tool in the process of developing a novel drug formulation. Selvita's highly qualified staff performs those analysis using appropriate modern laboratory equipment.

Impurity profile determination

Thanks to the state-of-the-art facilities and laboratory equipment Selvita offers stability study and impurity profile determination of the active pharmaceutical ingredient (API). Those results might be supplemented by the genotoxicity study of the identified impurities.

Genotoxicity studies

The analysis of potential genotoxicity (mutagenicity) of API impurities is an important element of its safety assessment. We offer two main assays for genotoxic properties of substances, defined by OECD TG 471 and OECD TG 487 guidelines, respectively.

AMES test

For early genotoxicity assessment Selvita offers high-throughput, pre-validated and precise Ames test (bacterial reverse mutation assay) with the use of optimized reagents and protocol. Ames test is commonly employed as an initial screen for genetic toxicity activity and point mutation-inducing activity of compounds and products of either cosmetic, pharmaceutical, biotechnology or industry companies.

Analytical assays required for clinical trials

Selvita offers comprehensive services related to testing of drug bioequivalence that require a complex approach. State-of-the-art facilities and software used in these studies enable Selvita the identification of drugs in biological material with the highest sensitivity, precision and specificity, as well as the determination of pharmacokinetic parameters that are indispensable in evaluating drug bioequivalence.

Drug registration dossier

Selvita offers support in the preparation of registration dossiers in accordance with the CTD format requirements of the International Conference on Harmonization (ICH).