Our Specialities
for your safe products.

You have complex questions,
we have the special solution.

Sterility testing (radioactive).

Are you looking for reliable, precise and timely
sterility tests for your products?

Sterility is crucial to ensure the safety and efficacy of your injectables and radioactive pharmaceuticals.
We perform sterility testing using two main monographed methods according to Ph.Eur. 2.6.1 and USP <71>:

  • Membrane filtration: The product is filtered through a special membrane that retains microorganisms. The membrane is then cultivated within a nutrient media to detect microorganisms.
  • Direct inoculation: This method introduces the product directly into culture media. It monitors whether microorganisms are growing.
  • Handling of high doses of radioactivity: We are able to accept and safely handle high doses of radioactivity.
  • Patent-protected processes: We work with unique technologies for your safety and efficiency. Both our membrane filtration method and the use of our isolator are patented.

Customer voices

We value the reliable collaboration and high quality of sterility testing that the laboratory provides for our radioactive pharmaceuticals. Their expertise enables us to deliver consistently safe and effective products.

Prof. Dr. Gerald Reischl,

Head of Radiopharmacy at Universitätsklinikum Tübingen

Operational hygiene monitoring
(WFI/purified water).

You wish to get reliable, precise and comprehensive hygiene monitoring services for production facilities?

In order to continuously guarantee the safety and purity of the production process, we test the water used microbiologically, regarding TOC (Total Organic Carbon) and particles in accordance with Ph.EU methods 2.6.14 and 2.2.44:
  • Microbiological testing: We analyze the water for microbial contamination. This ensures that no harmful microorganisms are present.
  • TOC analysis: We measure total organic carbon to quantify the organic load of the water and ensure its purity.
  • Particle testing: We check the water for particles to ensure physical purity and identify impurities.


Do you want to ensure that your solid dosage forms have a controlled and reliable dissolution of the active ingredient, including narcotics?

We carry out dissolution studies using advanced technologies:

  • UV detection: For the precise determination of active ingredient dissolution.
  • HPLC detection: For detailed analysis and quantification of dissolved active ingredients.
  • Narcotic analysis: Specialization in the analysis of narcotics.

Particle (visible / non visible).

Ensuring that sterile products do not contain harmful particles - for greater safety and effectiveness.

We analyze particles in sterile products with our ATR-FT-IR microscopy. This enables us to find and identify the exact cause of particles:

  • Finding the cause: We not only identify the particles themselves, but also their exact cause.
  • Advanced microscopy: The use of ATR-FT-IR microscopy offers a precise and detailed analysis that sets us apart from other laboratories.

Leachables / Extractables​
(LC-MS / GC-MS / GC-DER​).

Do you want to ensure that your container closure systems do not release leachables and extractables?

To ensure the safety and quality of your products, we analyze container closure systems using advanced technologies:

  • High-resolution mass spectrometry: Precise identification and quantification of leachables and extractables.
  • HPLC and GC incl. Headspace: Efficient separation and analysis of chemical compounds.
  • ICP-MS: Detection of trace metals and other elements..​

Gas chromatography (GC)
for content, purity and identity.

We meet the highest standards of purity and content
for your products.

We carry out GC analyses, especially for the analysis of residual solvents, method development and validation:

  • Head-Space and direct injection:For different sample preparations.
  • Various carrier gases: Nitrogen, hydrogen, helium.
  • Various detectors: FID (flame ionization detector), MS (mass spectrometry).

Elemental analysis.

Would you like to know the elemental composition of your products, especially peptides? For example, to calculate the net peptide content using the molecular formula?

We carry out elemental analyses under GMP conditions in order to precisely analyze even small amounts of substances:

  • GMP-compliant: Ensuring the highest quality and safety standards through GMP-compliant processes.
  • Efficient analysis: Precise results even with small amounts of substance.
  • Specialization in peptides: Special expertise in the elemental analysis of peptides and the calculation of the net peptide content.


You want to ensure that your products comply with the ICH Q3D guidelines and are free from
harmful elemental impurities?

We carry out analyses of elemental contaminants using advanced technologies:

  • ICP-MS and AAS/AES: High-precision methods for the determination of elemental impurities.
  • Method development and validation: Strong expertise in the development and validation of new methods.
  • Modern digestion technology: Use of Turbowave digestion for maximum accuracy.
  • Efficient analysis: Precise results even with small amounts of substance.

Stability tests
for the highest quality standards.

Do you want to ensure that your products, including narcotics and radioactive drugs, remain stable over the entire shelf life remain stable?

We analyse that your products remain stable throughout their entire shelf life:

  • Chemical and microbiological analysis: All relevant tests in-house.
  • All climate zones: Stability studies carried out in all climatic conditions.
  • Photostability: Additional testing of light stability.
  • Narcotics and radioactive pharmaceuticals: Specialization in the stability of narcotics and radioactive pharmaceuticals.

High Performance Liquid
Chromatography (HPLC)
for purity, content and identity.

Do you want to ensure that your products
meet the highest requirements?

We carry out HPLC analyses with a variety of detectors:

  • DAD (Diode Array Detector).
  • RI (Refractive Index Detector).
  • ELSD (Evaporative Light Scattering Detector).
  • MS/MS (Mass Spectrometry).
  • Radio detector.


We have been growing together with CUP Contract Labs for two decades and have enjoyed a fruitful partnership. They have proven to be a competent partner for the development and validation of our methods. Their reliable support in the release of our products makes them an indispensable part of our success.

Jens Junker,

Managing Director

at ROTOP Pharmaka GmbH

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