Analytical Laboratory

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

Total of 22 HPLC, 2 UPLC, 2 GC and 1 IC.

• Agilent 1100 Series quaternary HPLC (6 units).
• Agilent 1200 Series binary HPLC (2 units).
• Agilent 1200 Series quaternary HPLC (3 units).
• Agilent 1200 Infinity II HPLC (4 units).
• Waters E2695D HPLC (1 unit).
• Waters E2695 HPLC (6 units).
• Waters Acquity UPLC H-Class Systems (2 units).
• 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.

All the chromatographic stations are equipped with a PDA detector. Additionally, the following detectors are also available:

•  Fluorescence detector (2 units).
• Refractive index detector (1 unit).
• Evaporative Light Scattering Detector (1 unit).

Total of 8 dissolution baths.

• Sotax AT7 Smart dissolution bath coupled to Agilent 8453 UV for continuous dissolution tests (2 units).
• Sotax AT7 Smart dissolution baths coupled to fraction collector C613V for the automatic sampling of vials (2 units).
• Erweka DT700 dissolution bath for manual sampling (1 unit).
• Agilent 708-DS dissolution bath coupled to fraction collector 850-DS (3 units). 1 unit is coupled to Cary60 UV-Vis for online dissolution tests.

• 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.

• 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.

• Sotax Media Preparation Station.
• Erweka TA 100 friability tester.
• Erweka TBH 30 hardness tester.
• Mettler Toledo DL 38 volumetric Karl Fischer titrator.
• Mettler Toledo T50 titrator.
• Mettler Toledo HB 43 moisture sensor analyzer.
• Memmert VO400 vacuum oven.
• Carbolite ELF11/6B furnace.
• Mettler Toledo scales.

• Nugenesis lab management system (Waters).
• Empower 3 chromatography data software (Waters).
• Empower gel permeation chromatography (GPC) software (Waters).
• Method validation manager (MVM, Waters).