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FDA Laboratory

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Drug quality and bioequivalence analysis department

 

Drug quality and bioequivalence analysis department carries out
  • routine assays of raw materials and various pharmaceutical dosage forms according to Pharmacopoeial monographs (BP, Eu.Ph, USP, JP etc.)
  • in-house and other analyses based on STD certificates submitted by the customers
  • in vivo/in vitro bioequivalance studies, along with pharmacokinetic assays
  • new analytical method development
  • validation of analytical method: validation of an existing method (represented by the customer) development of new method followed by validation (validation points previously agreed with the customer)
  • development and validation of an analytical method carried out using available analytical instruments
Drug quality and bioequivalence analysis department provides
  • a complete validation report: validation plan, validation proposal (including validation points) and the final report
  • description of the analytical methods
  • formulation of new STD based on pharmacopoeial monographs (BP, USP, JP etc.)
  • all documents in three languages: Armenian, Russian or English (preliminarily agreed with the customer)
Department is equipped with following main facilities
  • LCMS Agilent, USA - liquid chromatograph/ mass spectrometer
  • HPLC Knauer, Germany - high performance  liquid chromatographs
  • 450-GC-MS Bruker, USA - gas chromatograph/ mass spectrometer
  • 450-GC Bruker, USA - gas chromatograph
  • ICS -900 / 1100 Dionex, USA - ion chromatograph
  • 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 analysis 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