Pharmaceutic tests

One of the key research areas of FEPtest is the pharmaceutical industry. Method developments: our laboratory has the appropriate level of knowledge and experience to develop analytical systems / methods. If we can support method development and method validations with large-scale instrument analytical methods (HPLC devices (DAD, FLD, VWD, MS / MS and QTOF-MS detectors), GC devices (FID, MSD and MS / MS detectors) and ICP-MS).

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Method developments

Our laboratory has the appropriate level of knowledge and experience to develop analytical systems / methods. If we can support method development and method validations with large-scale instrument analytical methods (HPLC devices (DAD, FLD, VWD, MS / MS and QTOF-MS detectors), GC devices (FID, MSD and MS / MS detectors) and ICP-MS).

As a point of reference, we perform the following tests:

  • Determination of nitrosamine impurities in raw materials and end-products,
  • Identification of nitrosamine impurities,
  • Identification of unknown impurities,
  • Establishing pollution profile
  • Examination of elemental impurities with ICP-MS.

Analytical method transfer

In our laboratory, the customer not only has the opportunity to acquire analytical methods, but also to optimize and validate their existing methods - which is confirmed by the implementation of several of our successful projects.

Batch release

During product release, our GMP-certified laboratory provides the necessary analytical examinations. The product is released by a FEPTEST Certified Person (QP), based on a Certificate of Analysis containing measurement results. Considering the services provided by QP (such as liability as a qualified person, issuance of a QP certificate, preparation of GMP-related documentation, professional support for establishing and developing quality assurance systems), the customer fulfills all legal obligations.

Stability examinations

Our laboratory also has stability chamber capacity and its own stability test protocol, which is available to our customers on request.

Miscellanous tests

The FEPtest laboratory has instrumentation in accordance with international pharmacopoeial requirements for large-scale instrument analysis, physical and chemical analysis of starting and intermediate products and finished products, such as:

  • Quantitative and qualitative determination of active substances
  • Identification of impurities and decomposition products
  • Determination of residual solvents
  • Classical analytical tests
  • Determination of water content with Karl Fischer method
  • Physical tests (abrasion resistance, size, weight, hardness, disintegration, etc.)
  • Dissolution test
  • Development, validation and verification of analytical methods with large-scale instruments (HPLC (DAD, FLD, VWD, MS / MS and QTOF-MS detectors), GC (FID, MSD and MS / MS detectors) and ICP-MS)

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Laboratory tests

Pharmaceutic tests

Method developments: our laboratory has the appropriate level of knowledge and experience to develop analytical systems / methods.

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Food tests

Our GMP-certified laboratory provides its customers with a wide range of food analytical methods to meet legal and regulatory

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Environmental analysis

Our environmental analysis examinations are currently mainly concerned with the analysis of soil and water samples for agricultural and environmental protection purposes.

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