Bioanalysis and Pharmaceutical Analysis - Prolytic

Pharmaceutical Analysis

Determination of Active Substance

The structure and physiochemical characteristics of the analyte to be examined as well as the detection limit desired give clues to which measuring instrument (HPLC, LC-MS/MS, ELISA-, LIA-Reader, Gamma-Counter) is best suited for the analysis.

The following detectors are available:

HPLC-analysis: UV-Vis, ECD, and fluorescent detectors.

With regard to LC-MS/MS-analysis, ESI- (Electrospray-Ionization) or APCI-sources (Atmospheric Pressure Chemical Ionization) are applied. Of course, we develop photometric methods or thin-layer-chromatography if other than the described methods are requested.

Method Development and Validation

The great choice of methods ensures qualitative and exact test results. Our validation is based on the current guidelines of EMA, FDA, or ICH.
All validations of methods are generally conducted under GLP-guidelines. We offer other approaches upon special request of the client.

Assay and purity determination:

The determination of the assay and chromatographic purity of the active substance is relevant for both the storage of formulations as well as the direct examination of active substances.

Prolytic conducted several examinations of active substances and peptide-formulations according to GMP-guidelines in the past.

Record of  Impurity Profile

By means of specific examinations of active substances or mixtures of substances with HPLC-MS/MS, we are able to provide an impurity profile with the determined molecular weights, which allows conclusions about even very complex compositions of active substances.

Residue Analysis

The analysis of a great number of newly-developed substances, which partly have a highly toxic or hormon-like effect, requires a precise and very sensitive analytic method.

Plasticizers in synthetic objects often affect the health of human beings and animals.

With our measuring instruments we are able to provide you with exact information upon if and to what extent these substances are released by packaging material or other objects of everyday use.

Do you need more information or do you have any other questions?
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