ANALYTICAL DEVELOPMENT FOR RAW MATERIAL AND PHARMACEUTICAL PRODUCTS

InKemia IUCT group has been authorized by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spanish Agency for medicinal drugs and Sanitary Products) to perform quality control of medicines for human and veterinary us, and drugs under research (Nº 4155-E).

InKemia IUCT group also counts with ISO 9001:2008 certification by Lloyd’s Register for the design, research and development of new products, control systems and training for the pharmaceutical, alimentary, chemical and related sectors (Nº SGI 3201316).

 

Physicochemical Methods

Development of analytical methods for the identification, purification and determination of content by means of:

  • Separation and characterization of impurities and degradation products
  • Set up and optimization of methods according to the client’s specific needs.

Validation of methods determining the following parameters among others:

  • Problem solution stability
  • Accuracy
  • Repeatability (accuracy of the method)
  • Intermediate precision
  • Precision
  • Linearity
  • Selectivity
  • Robustness
  • Reproducibility
  • Detection Limit
  • Quantification limit

Microbiological methods

InKemia IUCT group performs the development and validation of the following microbiological methods:

  • Challenge test
  • Microbiological assay for vitamins, antibiotics ...

 

Analytical Techniques

  • Gas Chromatography- Flame Ionization Detector (GC-FID)
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • Gas Chromatography, Head Space
  • HPLC-UV
  • HPLC, Mass Spectrometry (MS)
  • Flame Atomic absorption spectroscopy
  • Graphite furnace atomic absorption spectrometry
  • FT-IR 
  • Molecular absorption spectroscopy, UV-Visible
  • NMR (400 MHz)Cromatografía de gases, espectrometría de masas(GC-MS)

ANALYTICAL DEVELOPMENT FOR NATURAL EXTRACTS

InKemia IUCT group has wide experience in the characterization and analysis of natural extracts of vegetable origin.

 

Physicochemical Methods

Development of analytical methods for the identification, purification and determination of concentration by means of:

  • Separation and characterization of impurities and degradation products
  • Set up and optimization of methods according to the client’s specific needs.

Validation of methods with the determination of the following parameters, among others:

  • Selectivity
  • Linearity
  • Accuracy
  • Precision
  • Robustness
  • Stability of the problem solution
  • Repeatability
  • Reproducibility
  • Detection Limit
  • Quantification limit

Microbiological Methods

InKemia IUCT group carries out the development and validation of the following microbiological method:

  • Methods of microbiological control
  • Challenge test
  • Microbiological assay

 

Analytical Techniques

  • Gas Chromatography- Flame Ionization Detector (GC-FID)
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • Gas Chromatography, Head Space
  • HPLC-UV
  • HPLC, Mass Spectrometry (MS)
  • Flame Atomic absorption spectroscopy
  • Graphite furnace atomic absorption spectrometry
  • FT-IR
  • Molecular absorption spectroscopy, UV-Visible
  • NMR (400 MHz)

IMPURITY CHARACTERIZATION

The High Throughput Experimentation department of InKemia IUCT group has vast experience working in the pharmaceutical sector solving regulatory requirements related to impurities, all this thanks to a multidisciplinary team of organic chemists and analysts highly qualified.

The activities that InKemia IUCT group can perform in this field are:

•    Development and validation of analytical methods for determination of related substances
•    Determination of impurities’ profile
•    Obtention of impurities by forced degradation
•    Isolation and purification of impurities from pharmaceutical products
•    Structural elucidation of isolated related substances (Synthesis of related substances to use as analytical standards or to confirm the structure of a previously isolated impurity)

Analytical Techniques
•    Preparative HPLC
•    Analytical HPLC
•    MS, MS-MS and MS Exact
•    1H and  13C NMR
•    FTIR

Characterization of Impurities

The High Throughput Experimentation department of InKemia IUCT group has vast experience working in the pharmaceutical sector solving regulatory requirements related to impurities, all this thanks to a multidisciplinary team of organic chemists and analysts highly qualified.

The activities that InKemia IUCT group can perform in this field are:

  • Development and validation of analytical methods for determination of related substances
  • Determination of impurities’ profile
  • Obtention of impurities by forced degradation
  • Isolation and purification of impurities from pharmaceutical products
  • Structural elucidation of isolated related substances (Synthesis of related substances to use as analytical standards or to confirm the structure of a previously isolated impurity)

Analytical Techniques

  • Preparative HPLC
  • Analytical HPLC
  • MS, MS-MS and MS Exact
  • 1H and  13C NMR
  • FTIR

Pipeline

As a result of its own R&D activities, IUCT has a large pipeline of products, processes and technologies, developed in all the different areas during the last 11 years and protected by several patents and industrial secrecy:

  • Drug Discovery and HTA Platform: 4 specific chemical libraries targeting anti-inflammatory, central nervous system, cancer and arthritis and 5 new technologies.
  • Green Chemistry-Biotechnology Platform: 8 different products, 2 new processes and 3 new technologies.
  • Sustainable Chemistry Platform: 10 products or families of products, 5 different technologies and 5 new technologies.
  • Drug Development Platform: 2 new product formulations and 5 technologies developed.

For more information about the pipeline, please click on the image below:

 

pipeline

Investigación a medida

Events

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Contact

  •   info@inkemia.com
  •  +34 93 579 34 32
  •  +34 93 570 57 45
  •  C\ Àlvarez de Castro, 63, 08100
    Mollet del Vallès (Barcelona)