About Us

Company

PolyCrystalline provides reliable solutions to optimise and control the crystallisation process of Active Pharmaceutical Ingredients for pharmaceutical companies, since 2005.

Our mission is to support our clients during drug development, helping them to reduce batch failure, avoiding costly crystallisation issues and overall offering greater confidence in drug quality during manufacturing. We can support you from early-phase drug discovery to kilogram supply.

Why we are different?

 

We are a high performing cohesive team of trained chemists and analysts, with more than 10 years of experience in the development and optimization of APIs crystallization.

We care about results and innovation based on sound science and the use of modern technologies.

About Us

Equipment and Capabilities at a glance

  • XRPD (PANalytical X’Pert3 Powder)
  • XRPD (RIGAKU Miniflex 600)
  • XRPD Single Crystal (SC-XRPD)
  • Variable Temperature XRPD (VT-XRPD)
  • FT-IR/FT-RAMAN (Thermo Nicolet iS50)
  • Form Determination/Quantification
  • Inductively Coupled Plasma MS (ICP-MS)
  • Scanning Electron Microscopy (SEM)
  • Solid State NMR (Bruker AVANCE II 400)
  • PLM (Motic Microscope BA210)
  • BET Surface Area(Micromeritics TriStar II)
  • PARTICLE SIZE AND SHAPE (Malvern Morphologi G3)
  • PSD (Malvern Mastersizer 3000)
  • Liquid State NRM (NMR)
  • DISSOLUTION (Agilent 708-DS)
  • SOLUBILITY (Avantium Crystal16)
  • CHEMICAL IDENTITY (Agilent ACQUITY)
  • CHEMICAL PURITY (HPLC UV, DAD, ED, RI, FL)
  • WATER CONTENT (Mettler-Toledo Karl-Fischer)
  • DYNAMIC VAPOUR SORPTION (DVS SMS Intrinsic)
  • DSC (Mettler-Toledo DSC)
  • TGA-EGA (Mettler-Toledo TGA coupled Thermo Nicolet iS 10IR)
  • TGA (Mettler-Toledo TGA)
  • GC (Agilent 7820A)
  • Hot-Stage Microscopy (HSM)
  • Viscosity / Disco-Elasticity
  • Flowability / Aeration
  • Shear Cell / Wall Friction
  • Compressibility / Permeability
  • Bulk / Tapped Density
  • Multi-purpose Kilolab units ideal to run experiments at kilo scale during development.
  • Mettler-Toledo EasyMax (50 mL÷100 mL)
  • Atlas Jacketed Reactor (50ml÷5L)
  • Pressure Reactor (up to 5L)
  • Particle size and count (FBRM G400 MT)
  • FT-IR (ReactIR 15 MT)
  • UV-vis (UV-Vis Cary50)
  • Heat Flow Calorimetry (EasyMax102 HFCal)
  • Temperature, Turbidity and pH
  • Vacuum filtration
  • Agitated filter drier (up to 2L)
  • Centrifuge
  • Buchi B-290 Spray Dryer
About Us

Certifications

FDA inspected test facility for the analysis of pharmaceutical products.

Our analytical department is certified to work according to GMP by AIFA.

The GMP certification includes:

  • X-ray powder diffraction analysis (quantitative/qualitative)
  • FT-Raman (quantitative/qualitative)
  • FT-IR (quantitative/qualitative)
  • PSD

PolyCrystalLine received the authorization N°487/2016 from the Italian Ministry of Health for the study and chemical/physical analysis of controlled substances.