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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Dynamic Vapor Sorption (DVS)

Dynamic Vapor Sorption (DVS) is a gravimetric technique that measures the quantity, and how quickly water vapor is adsorbed and/or absorbed by a material, such as cement, or an active pharmaceutical ingredient. The DVS system works by flowing precisely controlled concentrations of water vapors in dry air over a sample at a known flow rate and temperature. The sample rests on a digital microbalance which detects the sorption/desorption of water vapor through the increase or de

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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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Physicochemical Properties

Understanding the physicochemical properties of a compound is essential so that the formulation process can be rational and streamlined. CRYSTAL HABIT (Malvern Morphologi G3) PSD (Malvern Mastersizer 3000) NRM (Liquid State NMR) DISSOLUTION (Agilent 708-DS) SOLUBILITY (Avantium Crystal16) CHEMICAL CHARACTERIZATION (Agilent ACQUITY) CHEMICAL PURITY (Thermo Scientifics UltiMate 3000, etc.) WATER CONTENT (Mettler-Toledo Karl-Fischer) Melting Point (MP) pKa / LogP / LogD determination

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Rheological Properties

The measurement of the physical properties of granular materials is an essential step during the development or the optimization of an industrial process. PolyCrystalLine can now support you to understand and control granular material behaviours of your products. Flowability Aeration Shear Cell Compressibility Permeability Viscosity and disco-elasticity Wall Friction Bulk / Tapped Density

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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. XRPD (PANalytical X'Pert3 Powder) XRPD (RIGAKU Miniflex 600) XRPD Single Crystal (SC-XRPD) Variable Temperature XRPD (VT-XRPD) Amorphous vs. Crystalline Solid State Testing Crystal Structure Determination Single Crystal Growth FT-IR/FT-RAMAN (Thermo Scientific Nicolet iS 50) Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Scanning Electron Microscopy (SEM) Solid State NMR (s.s. NRM) PLM

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Thermal Analysis

Thermal data serve as an indicator of conformational stability, reaction-rates and composition of the sample. DSC (Mettler-Toledo DSC) TGA-EGA (Mettler-Toledo TGA coupled with Thermo Scientific Nicolet iS 10 IR) TGA (Mettler-Toledo TGA) GC (Agilent 7820A) Hot-Stage Microscopy (HSM)

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