cGMP Analyses

We provide a full complement of state-of-the-art GMP analytical testing resources and expertise to support the cGMP analyses for raw materials, active pharmaceutical ingredients (API) and intermediates.

• FT-IR
• FT-RAMAN
• X-Ray Powder Diffraction (XRPD)
• Particle Size Distribution (PSD)
• Surface Analysis (BET) DSC

Method Development and Validation

Polycrystalline has a proven record of excellence in developing analytical methods throughout the entire drug lifecycle.
Our approach follows ICH guidelines, including preparation of validation protocols and reports to be shared and agreed with our clients.
The validation of each method will meet your quality needs at each development stage providing cost-effective solutions.

Quality Control

Material science in pharmaceuticals requires the expertise to evaluate each API using a variety of techniques.

In Polycrystalline we can support your API characterization using Polarizing Light Miscroscopy (PLM), SEM (Scanning Electron Microscopy) Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Light scattering Particle Size, and X-Ray Powder Diffraction (XRPD).

Our capabilities are not limited to the listed above, our know-how goes beyond that and here the list of the techniques available at Polycrystalline

SPECTROSCOPIC ANALYSIS

• FT-IR (Thermo Scientific Nicolet iS 50) GMP
• FT-RAMAN (Thermo Scientific Nicolet iS 50) GMP
• SSNMR (Solid State NMR) – Physicochemical Properties

CHEMICAL CHARACTERIZATION

• LC-MS (Waters Aquity)
• NMR (Liquid State NMR)
• ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
• SEM –EDX (Scanning Electron Microscopy)

CHEMICAL PURITY

• HPLC/UPLC (equipped with UV, DAD, FLD, EC, RI)
• Gas Chromatography (Agilent 7820A)
• Hot-Stage Microscopy (HSM)

CRYSTAL MORPHOLOGY

• Particle Shape/Size Distribution (Malvern Morphologi G3)

POWDER PROPERTIES

• BET (Micromeritics Gemini VII) GMP
• Powder Rheometer (Freeman FT4)

WATER CONTENT

• DVS(Dynamic Vapour Sorption SMS Intrinsic)
• KF
• (Mettler-Toledo Karl-Fischer)

Dissolution and Solubility Studies

The experience and knowledge in pharmaceutical dissolution within Polycrystalline focus on supporting preformulation studies and solid form selection.

The dissolution testing is never a routine test, but is a highly customized essential tool in pharmaceutical development.

We evaluate the physico-chemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation).

We perform biorelevant in-vitro tests to mimic fed and fasted state conditions compare prototype formulations (preclinical selection).

Our available equipment:

• 2X Avantium Crystall 16: (Thermodynamic Solubility)
• Agilent 708-DS (apparatus 2): intrinsic solubility and dissolution profile
• Sotax apparatus4: (Dissolution Profile flow through cell)