What is it?
Thermal analysis is used for drug substance physical form assessments, particularly the determination of crystalline and amorphous components.
How does it work?
We offer both Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA). Thermogravimetric Analysis (TGA) measures the mass of a sample as the temperature changes, and can be applied to salt selection and polymorph screening. DSC is frequently used for polymorph or amorphous form quantification. It can also be employed for determining excipient compatibility during formulation development.
Why choose Arcinova?
Our clients benefit from our collaborative approach to analytical services. All our teams will work together to provide you with the robust data required at every stage of your project.
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Liquid/Solid State NMR is used to provide data about the materials science aspect of APIs and their products. Understanding molecular structures and their dynamics is fundamental to the drug discovery and development process.
How does it work?
Solid-state NMR is a non-destructive and non-invasive technique that is used to determine the structure and dynamics within solid drug substances and drug formulations. We also offer liquid-state NMR to provide a means of rapid structure elucidation. Our facilities enable us to offer this service for a wide range of applications, including those requiring the analysis of Carbon-14 material.
Why choose Arcinova?
We combine cutting-edge technology with interpretive expertise to provide our clients with quality data. Our all-in-one facility permits an integrated approach to problem solving and we can work with you to develop a plan to fulfil all your analytical service needs.
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Microbial analysis is essential for ensuring that pharmaceutical products are safe and meet rigorous quality and regulatory specifications. We support formulation development, clinical manufacturing and quality control for both non-sterile and sterile products.
How does it work?
Our work supporting formulation development includes preservative efficacy testing and customised challenge analysis to determine product shelf-life. We provide endotoxin testing results as part of the release tests prior to dosing. Arcinova’s on-site microbiologists can assist manufacture through microbial monitoring and simulation tests. An advantage of having specialists close at hand during process testing is that samples can be taken as close to the source as possible.
Why choose Arcinova?
Our skilled microbiologists excel at developing microbiological methods. Their extensive experience permits testing of difficult products that have not previously been analysed. We are specialists at the microbial analysis of radiolabelled compounds and are able to handle cytotoxic and high potency compounds. Our flexible approach allows us to offer both on-site microbiological testing and analysis of products made off-site.
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Stability testing produces robust data to determine how a product changes over time. Our team also tests the influence of environmental factors such as temperature, humidity and light.
How does it work?
Our work enables clients to be confident of the essential storage-dependent characteristics of their product. Stability testing is used to develop suitable re-test dates or shelf-lives during all clinical phases. We employ our state-of-the-art, 'walk-in', ICH compliant stability chambers and a number of smaller, reach-in, units for investigative studies.
Why choose Arcinova?
The Arcinova Quality Control (QC) testing team is responsible for the analytical testing of material within drug substance, drug product and isotopic labelling divisions. Whatever the stage of your drug development project, we have the skills to provide you with the quality stability data you require.
Get In TouchWhat is it?
The Arcinova Quality Control (QC) testing team is responsible for the analytical testing of material within drug substance, drug product and isotopic labelling divisions. We supply high quality stability testing, which is critical for ensuring suitable re-test dates or shelf-lives are applied during all clinical phases. Our in-house Qualified Person (QP) certifies Investigational Medicinal Products (IMP) for distribution to clinical trials.
How does it work?
We follow British and US pharmacopeia reference standards for testing raw materials and excipients. Our full stability testing allows clients to be confident of the essential storage-dependent characteristics of their product. Forced degradation studies are also used to determine what happens to material during severe and accelerated conditions. Our identification services utilise a wide range of equipment to determine material characteristics, including mass-spectroscopy, NMR, X-Ray Diffraction and Refractive Index Detectors.
Why choose Arcinova?
We can offer full GMP QC testing and QP release on-site, alongside a flexible approach for clients that require technical transfer for testing. Our dedicated team of experts are always ready to provide suggestions for improvements.
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Chromatographic services are used to identify drug impurities or degradation products by separating individual components.
How does it work?
Our team utilises their extensive experience to develop, validate and apply GC (headspace or direct injection), ion chromatography, LC and UPLC-based methodologies. Our facilities include a range of LC detector types including UV, DAD, N2 emission, radiochemical, ICP-MS, conductivity, fluorescence and CAD. Our LC/MS technologies comprise single quadrupole, triple quadrupole and accurate mass.
Why choose Arcinova?
We provide chromatographic services for both discrete projects, and as part of a fully integrated service. By combining chromatographic separation/isolation methods with other analytical technologies, our scientists can offer a complete service for the identification of impurities and degradation products.
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