DISSOLUTION

Erweka Dissolution DT800 dissolution apparatus with attached PerkinElmer Lambda25 UV / Vis Spectrophotometer for on-line quantification, or Erweka fraction collector facilitating off-line quantification via HPLC. For API / API-excipient / process intermediate formulation development, and intermediate / finished product release testing. USP I and USP II configurations.

Waters Alliance 2695 and Jasco 1500 Series HPLC systems, providing API potency and impurity assays, quantification of the active in e.g., dissolution / cleaning verification samples. Gradient elution with PDA, UV, RI, Conductivity and Fluorescence detection systems.

STABILITY SERVICES

On site stability cabinets with 400L capacity operating with Relative Humidity of 50% to 80% and Temperature 20ºC to 50ºC, off site capacity covering all ICH conditions and sufficient capacity for all stability studies.

RESIDUAL SOLVENTS

PerkinElmer Autosystem XL Headspace-GC with Turbomatrix 40 autosampler, providing residual solvent analysis of powder and dosage form samples. Validated methods in place for a wide range of standard and non-standard organic solvents. FID detection. PerkinElmer TurboChrom software. 

Automated price quoting and ordering systems to streamline sample handling. 

VOLATILES PRESENT

Analysed using a variety of techniques, including: PerkinElmer Pyris 1 Thermal Gravimetric Analyser for Loss on Drying calculations, this has a 20 position autosampler with Accupik accessory for this purpose, it operates in the ambient to 1000ºC range, identification of volatiles is via PerkinElmer Autosystem XL Headspace-GC and Mettler Toledo DL39 Karl Fischer Coulometer this latter equipment operates in the 1ppm to 5%. Range, can store up to 50 methods and can operate on an automated basis.

POTENCY ASSAY / IMPURITY ASSAY

Waters Alliance 2695 and Jasco 1500 Series HPLC systems, providing API potency and impurity assays, quantification of the active in e.g., dissolution / cleaning verification / cascade impactor samples. Gradient elution with PDA, UV, RI, Conductivity and Fluorescence detection systems. Networked Waters Empower and Jasco Borwin software as appropriate.

Jasco FT/IR-420 for e.g., identification testing of raw materials (actives, excipients, solvents, gases, packaging), drug quantification. "Golden Gate" attenuated total reflectance configuration (testing of powders, films, tablets & liquids), gas cell and transmission cell (solids & liquids) sample presentation.

PerkinElmer Lambda20 UV/Vis Spectrophotometer, faciliatating quantification of drug content, as well as enzyme assays, calibration curves, specificity testing etc.

SUPPORTING MANUFACTURING PROCESS VALIDATION

With a wide range of qualified analytical equipment in place, as manufacturing key operating parameters and quality control specifications are established, we can provide support via design of experiments software.