Analytical development

Analytical method development can often be complex and time-consuming for our customers. It is not uncommon that there are challenges that were difficult to foresee at the project start up, and requirements differ depending on the stage of development.

To support route scouting and process development activities and to accelerate your clinical programs, we provide a comprehensive range of analytical services. Our analytical development and Quality Control teams have in-house access to a comprehensive range of state-of-the-art analytical techniques. We provide full stability studies alongside our analytical and quality control teams. We offer a full service of design, development, and review of early-stage analytical methods for assisting early-stage dosage form development as well as the design, development, and review of analytical method qualifications, preparing validation protocols and reports as per ICH / USFDA requirements. We provide full stability studies alongside our analytical and quality control teams.

We offer a full service of design, development and review of early stage analytical methods for assisting early stage dosage form development as well as the design, development and review of analytical method qualifications, preparing validation protocols and reports as per ICH / USFDA requirements. We provide full stability studies alongside our analytical and quality control teams.

Characterization studies

Obtaining the optimal physical form for your API is important as this impacts downstream product performance. Optimizing characteristics such as size/shape, particle size distribution, flow, density, bioavailability and melting point enables more efficient formulation and manufacturing process development at the drug product stage.

Formulation studies

We provide support and in-depth characterization expertise related to the development and stability assessment of all types of oral solid dosage forms. We have comprehensive experience and competence within the dry powder inhalation field and have assisted in progressing inhalation projects.

Instruments

We are constantly investing in our capabilities and modernizing our equipment and facilities. Our We are constantly investing in our capabilities and modernizing our equipment and faclilites. Our laboratories are fully equipped with a mix of modern state-of-the art instrumentation together with internally designed innovative equipment.

  • HPLC (High Performance Liquid Chromatography) 
  • GC, GC-HS (Gas chromatography, Headspace) 
  • UPLC-TUV (Ultra Performance Liquid Chromatography- Tunable UV detector) 
  • IC (Ion chromatography) 
  • PSD (Particle size distribution) 
  • FTIR (Fourier-transform infrared spectroscopy) 
  • UV-VIS spectrophotometry 
  • ICP-OES (Inductively coupled plasma-optical emission spectroscopy) 
  • Microscopy 
  • Titration 
  • Optical rotation 
  • Halogen moisture analysis 
  • Density
  • Refractive index 
  • Melting point by hot stage microscopy 
  • Photo stability


Talk to one of our specialists

Magnus Persson
Magnus has a Master of Science from Lund University. He has worked with QC and Analytics at Magle Chemoswed since 2006 and is our currently our Instrument Specialist.

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