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Stability Studies Reference Standards Service

ICH Stability
Studies Services

Drug substance stability studies for APIs and the associated stability data are required by regulatory agencies, such as the FDA in the U.S., the EMA in Europe and other authorities, for new drug products approval and to ensure the quality of marketed products.

  • Full range of ICH stability studies and reference standard services that comply with the International Conference on Harmonization (ICH)
  • Services provided by senior scientists with over 25 years’ experience in analytical chemistry, especially for HPAPIs
  • Our experienced scientists work closely with clients to select the necessary and stability-indicating tests for each stability study
  • Customized approach to exceed our clients’ expectations and reduce time and cost

Stability Studies Services

ICH Stability Studies and Stability Testing

At CARBOGEN AMCIS, we run stability studies to demonstrate the conditions under which the material will not degrade over time.

Conducted in fully cGMP, validated and mapped stability chambers, our stability program complies with ICH Q1a, including long-term, intermediate and accelerated studies, as well as customized stability testing.

Further we are able to do stability studies at reduced temperature (5°C / -20°C or -80°C) to meet customer product requirements. Our forced degradation studies, including acid, alkali, oxidative stress and photostability studies, and other possible conditions give us information on the stability of the active ingredient to these environmental influences.

In close cooperation with the customer, we design tailor-made stability programs for starting materials, intermediates and finished products that cover all necessary stability aspects in accordance with regulatory requirements. We handle both the storage of samples in accordance with requirements and the performance of analytical measurements under cGMP. In addition to ICH Q1a-compliant registration studies, we also carry out special studies (forced degradation studies, transport studies and similar) if required. The results, including the statistical evaluation and an assessment of the results, are summarized in detailed reports.

In-house Stability Chambers

Stability testing in controlled environmental conditions is a regulatory requirement for the approval of new drug substances or drug products and for the ongoing quality assurance of existing products.

Our stability chambers provide companies with the capability to perform accelerated stability studies in accordance with global standards to ensure products are stored after manufacturing to meet the required safety, and quality criteria throughout their intended shelf life. Stability chambers allow for the exposure of products to different environmental conditions, such as temperature and humidity to determine the physical, chemical, and microbiological changes of the product during storage. The influence of the packaging material can also be investigated during storage. These tests enable the customer to choose a packaging material that has a positive influence on the shelf life of the product.

CARBOGEN AMCIS supports the full range of ICH conditions in our in-house stability chambers. Our chambers are capable of maintaining a range of environmental conditions, such as:

  • 25°C / 60% RH,
  • 30°C / 65% RH,
  • 30°C / 75% RH,
  • the more stringent 40°C / 75% RH,
  • as well as specialized settings for products requiring storage at 5°C, -20°C,
  • and even as low as -80°C.

Such flexibility ensures that our stability studies can accommodate products destined for global markets, regardless of climatic zone. In addition, the integrity of our testing environment is protected around the clock as all systems are connected to an alarm system with a 24/7 emergency response team.

CARBOGEN AMCIS is committed to delivering excellence in pharmaceutical development, ensuring that every product tested in our in-house chambers is stable, safe, and compliant with international standards.

Reference Standards Services

Reference Standards Characterization

Reference standards play an important role in the regulatory compliance efforts of the pharmaceutical industry for example during intermediate and final product releases.

The characterization of standards is critical to quality control processes, as it allows companies to verify the quality, purity, and potency of their products between the individual production batches.

CARBOGEN AMCIS provides reference standard characterization services to support drug development and quality control processes.

Our Reference Standards Characterization Services

We provide and perform:

  • Full structure confirmation with advanced 1D/2D NMR, MS and X-ray analysis with an unmatched level of detail and accuracy
  • Purity and profile of substances can be determined using sophisticated HPLC (High-Performance Liquid Chromatography) or GC (Gas Chromatography) methods
  • Accurate water content determination is performed by the Karl Fischer analysis method
  • Residual solvent analysis with GC/HS (Head-Space Gas Chromatography), which is the most reliable method for residual solvent analysis and follows all regulatory guidance
  • A range of other analytical tools are available to our team for thorough compound analysis, including FTIR (Fourier-Transform Infrared Spectroscopy), UV spectroscopy, GC/MS (Gas Chromatography coupled with Mass Spectrometry)
  • Loss on drying (LOD) and Differential Scanning Calorimetry (DSC) provide a full understanding of material properties

With CARBOGEN AMCIS, customers receive precisely characterized reference standards, through which results are obtained with high reliability during the performance of the analyses. These standards and the methods used can therefore ensure compliance with global regulatory guidelines.

Reference Standard Types and Services

CARBOGEN AMCIS meets the demands of pharmaceutical development and quality control by providing a wide range of reference standards services.
We offer several reference standard (RS) types, such as:
  • Primary reference standard (PRS), the most widely used quantitative standards for intermediates and APIs
  • Semi-quantitative reference standard (SRS) are essential for quantifying impurities at low levels, such as in limit testing
  • Working reference standards (WRSs) are quantified against an established PRS and are therefore ideal for replacing the PRS in late project phases. This reduces the consumption of PRS and enables us to release many batches against a single reference point, which increases batch-to-batch comparability.
  • Comparison reference standards (CRSs) serve as non-quantitative reference standards, typically used as retention time markers for peak identification.

In addition to supplying essential standards, CARBOGEN AMCIS is dedicated to the qualification and re-qualification of reference standards to ensure continued availability and reliability. We also provide our customers with regular inventory and sampling report updates, as well as managing and storing reference standards in-house.

Our approach ensures that our customers have always access to qualified and valid reference standards to help develop safe and compliant pharmaceutical products.

For more information
download our
dedicated brochure