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FDA Laboratory

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Drug quality and bioequivalence analysis department

 

DRUG QUALITY AND BIOEQUIVALENCE ANALYSES DEPARTMENT IMPLEMENTS
  • pharmaceutical raw materials and dosage forms laboratory analyses according to Pharmacopoeial monographs USP, BP, Eu.Ph, JP etc.
  • in-house and other analyses based on STD certificates submitted by the clients
  • drug bioequivalance studies, as well as pharmacokinetic assays
  • validation of analytical methods, validation of existing methods, development of new analytical methods and its further validation (using available analytical instruments).
DRUG QUALITY AND BIOEQUIVALENCE ANALYSES DEPARTMENT PROVIDES
  • a complete validation report, validation plan, validation proposal, final report
  • description of the analytical method
  • formulation of new STD based on pharmacopoeial monographs (BP, USP, JP)
  • documents can be provided in three languages (Armenian, Russian, English).
DEPARTMENT IS EQUIPPED WITH FOLLOWING MAIN FACILITIES
  • LCMS Agilent, USA - liquid chromatography-mass spectrometer
  • HPLC Knauer, Germany - high performance  liquid chromatography
  • 450-GC-MS Bruker, USA - gas chromatography-mass spectrometer
  • 450-GC Bruker, USA - gas chromatography
  • ICS -900 / 1100 Dionex, USA - ion chromatography
  • AAS 7000 Shimadzu, Japan - atomic absorption spectrometer
  • Spectro UV meter MRC, Israel - UV Spectrometer.
DEPARTMENT IS EQUIPPED WITH FOLLOWING ADDITIONAL FACILITIES
  • P8000 A Kruss Optronic, Germany - polarimeter
  • Semi-Micro Osmometer K-7400 Knauer, Germany - osmometer
  • - 86OC freezers MRC, Israel - freezer
  • Analytical balances MRC, Israel analytical balance (D = 0,1 mg, D = 0,01 mg)
  • Centrifuges MRC , Israel - centrifuges (6000 rpm, 16000 rpm)
  • MSF MRC, Israel - muffle furnace
  • Sotax, Switzerland - device determining the non-film coated dosage form friability
  • Sotax, Switzerland - device determining the solid dosage form disintegration
  • Sotax, Switzerland - device determining the solid dosage form dissolution
  • pH-meter MRC, Israel - pH-meters
  • Vortex MRC, Israel - mixers
  • Ultrasonic bath MRC, Israel - ultrasonic baths
  • Millipore, France - water deionizer
  • MRC, Israel - vacuum dryer
  • MRC, Israel - magnetic stirrer hot plate
  • MRC, Israel - digital orbital shaker
  • MRC, Israel - rotavapor
  • Macherey-Nagel, Germany - solid-phase extraction device.
IN DRUG QUALITY AND BIOEQUIVALENCE ANALYSES DEPARTMENT
  • only certified reagents and standards are used in sample preparation
  • all devices are exploited according to standard operating procedures (SOP)
  • the National Metrology Institute of RA holds annual verification and issues the eligibility of analytical equipment along with application certificate
  • calibration of analytical devices is performed according to standard operating procedures for quality control assurance.

Laboratory
Complex 2012
"FDA Laboratory"LLC

International
Accreditation
2015 ANAB