Analytical Laboratory

Analytical Laboratory

 

Dedicated to the development and validation of analytical methods and the performance of quality controls, stability studies and microbiological control.

Chromatography

Total of 18 HPLC, 3 UPLC, 2 GC and 1 IC.

  • Waters Alliance e2695XE HPLC (4 units) coupled to photodiode-array 2998 detector.
  • Agilent 1100/1200 quaternary HPLC (6 units) and 1200 binary high pressure HPLC (1 unit) HPLCs coupled to photodiode-array detector.
  • Agilent 1100 quaternary HPLC (1 unit) coupled to variable wave length detector.
  • Agilent 1100/1200 quaternary HPLC (2 units) coupled to diode array and fluorescence detector.
  • Agilent 1200 binary HPLC (1 unit) coupled to diode array and refractive index detector.
  • Waters Alliance HPLC (2 units) coupled to PDA detector.
  • Waters Alliance HPLC coupled to PDA and Evaporative Light Scattering Detector (ELSD) detector.
  • Waters Acquity HPLC/UPLC H-Class systems (2 units) coupled to PDA detector.
  • Binary UPLC coupled to PDA detector.
  • Agilent 6890N gas chromatography system with “head space “, automatic injection and flame ionization detector (FID).
  • Agilent 7890B gas chromatography system with automatic injector and flame ionization detector (FID).
  • Dionex ICS3000 ion chromatography system coupled to conductivity detector.

Dissolution

Total of 7 dissolution baths.

  • Sotax AT7 dissolution bath coupled to Agilent 8453 UV for continuous dissolution tests (2 units).
  • Sotax AT7 Smart 230V dissolution baths coupled to fraction collector C613V for the automatic sampling of vials (2 units).
  • Erweka DT700 dissolution bath for manual sampling.
  • Erweka DFZ 60 flow-through cell dissolution tester (Apparatus IV USP).
  • Agilent 708-DS dissolution batch coupled to sampling station Agilent.

Stability Storage

  • Constant climate rooms for temperature and humidity control for stability studies, conditions 25ºC/60% RH and 30ºC/75% HR (2 rooms).
  • Binder KBF 720 constant climate chambers with temperature and humidity control for stability studies, conditions 30ºC/65% RH (3 chambers) and 40ºC/75% RH (2 chambers).
  • Binder KBF 720 chamber for ICH photo stability studies.
  • Refrigerator and freezer.

Microbiology Laboratory

  • Binder 22ºC KB 115 refrigerated incubator with forced convection for analysis of fungi and yeasts.
  • Binder 33ºC BD 115 incubator with cavity convection for bacteria analysis.
  • Memmert 43ºC UFE 500 universal oven for analysis of specific microorganisms.
  • Telstar BIO-II-A microbiological safety cabinets.
  • Telstar Cytostar biological safety cabinets for high potency.
  • Millipore Steritest Equinox Pump for sterile products.
  • Selecta Vapor P-Selecta autoclave model Presoclave-II-75.
  • Raypa AE-75-DRY autoclave with drying.

General Equipment

  • Sotax Media Preparation Station.
  • Erweka ZT121 disintegration tester.
  • Erweka TA 100 friability tester.
  • Erweka TBH 30 hardness tester.
  • Mettler Toledo DL 38 volumetric Karl Fischer titrator.
  • Mettler Toledo DL 50 titrator.
  • Mettler Toledo HB 43 moisture sensor analyzer.
  • Mettler Toledo 822E/200 Differential Scanning Calorimeter (DSC).
  • Memmert VO400 vacuum oven.
  • Carbolite ELF11/6B furnace.

Software

  • Nugenesis lab management system (Waters).
  • Empower 2 chromatography data software (Waters).
  • Empower gel permeation chromatography (GPC) software (Waters).
  • Method validation manager (MVM, Waters).

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