DETERMINE: Analytical services

Polycrystalline provides a full complement of state-of-the-art analytical testing resources and expertise to support quality control testing and characterization of raw materials, active pharmaceutical ingredients (API) and intermediates.

We can acquire existing methods and validate them in our laboratories. Alternatively, we can provide method development in accordance to our client’s requirements.

 

STRUCTURAL CHARACTERIZATION: Quantitative and qualitative determination of crystal form.

 

 

PHYSICAL CHARACTERIZATION: Determination of all the physical properties of a material.

 

 

 

 

   

   

METHOD DEV. & VALIDATION: Analytical methods require development, validation, and controls just as all other product and process development activities.

 

 

THERMAL ANALYSIS: The properties of materials are studied as they change with temperature.

 

 

 

WATER CONTENT & ACTIVITY: Determine the interactions between your material and water.

 

 

 

 

   

cGMP QUALITY CONTROL: Testing for raw materials, APIs and intermediates to GMP specifications.

   

cGMP quality control

We provide a full complement of state-of-the-art GMP analytical testing resources and expertise to support cGMP quality control testing for raw materials, active pharmaceutical ingredients (API) and intermediates. FT-IR     Detects functional groups and characterises covalent bonding information. FT-RAMAN   Provides chemical structure information of the material. X-Ray Powder Diffraction (XRPD)   Provides phase identification of a crystall

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Method development & Validation

Polycrystalline can be entrusted with your most sensitive projects for method development and validation of API’s intermediates, raw materials and finished products. How can we help you? cGMP and non-GMP method optimization, qualification, validation and transfer. Wide range of analytical laboratory equipment.  

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Physical characterization

Understanding the physicochemical properties of a compound is essential so that the formulation process can be rational and streamlined. The size and shape of a statistically relevant number of individual particles can be investigated, significantly improving process understanding (i.e. morphology affects the ease with which a pharmaceutical formulation can be pressed into a tablet). Particle Size Distribution (PSD)       Determines information about the size and range

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Structural characterization

The characteristics of the unit cell can be used to predict the morphology and physical properties of a drug. X-Ray Powder Diffraction (XRPD)     Provides phase identification of a crystalline material and information on unit cell dimensions. XRD Single Crystal (SC-XRPD)   Provides detailed information about the internal lattice of crystalline substances, including unit cell dimensions, bond-lengths, bond-angles, and details of site-ordering. Variabl

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Thermal analysis

Thermal data serve as an indicator of conformational stability, reaction-rates and composition of the sample. They are also useful for determining sample purity and water, carbonate and organic contents and for studying decomposition reactions. Differential Scanning Calorimetry (DSC)      Measures how physical properties of a sample change, along with temperature against time. Thermogravimetric Analysis (TGA)   Determines a material’s thermal stability

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Water content & Activity

In the pharmaceutical industry, it is essential to know the amount of water contained in the individual active ingredients and excipients of a drug in order to correctly predict its lifetime, stability and effectiveness. Easy Water     Selectively determines the water content in a sample by means of thermo-coulometric determination. Karl Fischer Titrations   Moisture determination based on the amount of reagent used to convert the water. Dynamic Vapo

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