Stability Testing of Drugs

Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...

Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...

Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
-Formulation development studies including stress studies
-Photostability (Options I and II)
-Comparator studies
-Thermal cycling/freeze thaw
-Shipping excursion studies
-Long-term stabi...

From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...

The purpose of stability testing is to provide evidence on how the quality of drug substances or drug products varies over time under the influence of various environmental factors, such as temperature, humidity, and light. Selvita offers a comprehensive set of services related to stability studies for dif...

With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlle...

Includes analytical studies and evaluation of long-term stability, accelerated stability, photostability, comparative stability, storage and analytical studies

Contact us for more information.
contact@chemineau.com

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility...

Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio...

We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Phar...

Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ...

Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel...

To address the challenges of product related impurities including truncated and other modified forms, aggregates, precursors and other degradation products arising during processing and/or storage, we deliver detailed characterization in reference to the ICH Q6B Guidance using a diverse range of techn...

QC testing of pharmaceutical raw materials to international pharmacopoeia specifications has become a specialty of Intertek. With our knowledge of analytical chemistry and our vast range of instrumental techniques, we can undertake the vast majority of the chemical tests listed within the international pha...

Intertek offers wide range of pharmaceutical services which includes pharmaceutical powder and particle morphology. It belongs to pharmaceutical analysis services category. It includes dry powder analysis: physical characterisation, particle morphology using malvern morphologi g3, particle size analysis – ...

Intertek offers wide range of pharmaceutical services which includes physical characterization techniques for pharmaceuticals. Our experts can assist with formulation or process development, quality control, gmp lot release testing, and investigational manufacturing troubleshooting. It includes microscopy,...

Whilst your organisation focuses on your core business goals, you will need to select a contract analytical services partner with a strong history of delivering regulatory compliant testing to a consistently high standard. Our contract analysis services are focused on supporting product development, GMP ma...

Our GCP/GLP/GMP compliant laboratories provide genotoxic impurity testing services to detect and evaluate the potential of GIs for your API and/or drug substances which can support your product development from an early stage to market release. With scientists who are adept at method development and valida...

With 30 years of experience in supporting development of inhalation drug products for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, device verification testing,...