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    Pharma Services Category of Dannalab B.V

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Analytical Testing Services (8)

    02 Stability Studies (1)

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    01 Dannalab B.V (9)

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    Dannalab B.V

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      XRPD (XRD) TO STUDY POLYMORPHISM

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      XRPD (XRD) is an important analytical technique for the characterization of small-molecule drugs, providing direct information about the state of an active pharmaceutical ingredient (API). XRPD (XRD) patterns form an essential aspect of patent applications for new polymorphic forms.

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        XRPD (XRD) FOR API DEVELOPMENT

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        Since XRPD patterns are directly related to the crystalline structure of a material, this is an ideal technique for the screening, identification and characterization of polymorphic forms and new chemical entities in API discovery and development.

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          XRPD (XRD) TESTING OF THE QUALITY OF RAW MATERIALS

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          XRPD serves as an important tool for controlling purity, crystallinity and polymorphism for API and excipients.

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            XRPD (XRD) FOR PREFORMULATION & FORMULATION

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            The non-destructive nature of XRPD makes it a suitable technique for systematic preformulation studies and for testing drug-excipient compatibility. Excipient interactions are critical to the consistent release and bioavailability of the API.

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              XRPD (XRD) FOR MANUFACTURING & QC

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              XRPD is used to monitor the quality of the finished drug product by determining the micro-structural parameters of the API and by detecting and quantifying the presence of pharmaceutical polymorphic contaminations.

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                SMALL ANGLE X-RAY SCATTERING TO CHARACTERIZE BIOLOGICS

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                An advantage of this method is that it permits the observation of objects that have not been stained or fixed, showing them in their native aqueous environment (in contrast to X-ray crystallography, which generally requires placing the samples in non-physiological environments).

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                  SAXS FOR STABILITY STUDIES

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                  Information about the structural parameters obtained from the SAXS measurements, such as envelope shape and invariants (mass and radius of gyration), serve as important markers that are correlated with biological activity.

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                    CHARACTERIZATION OF NANOPARTICLES WITH SAXS

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                    At Dannalab we offer a range of analytical services devoted to the identification and characterization of nanoparticles - both in solid and liquid matrices.

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                      XRPD STUDY OF TRANSDERMAL PATCH

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                      XRPD characterization of a transdermal device may cover the properties of pharmaceutical formulation: crystallinity and polymorphic impurities in bulk or as distribution, or the material properties of patch components, such as- polymer structures, films and adhesives.

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