Drug quality and bioequivalence analyses department
DRUG QUALITY AND BIOEQUIVALENCE ANALYSES DEPARTMENT IMPLEMENTS
- pharmaceutical raw materials laboratory analyses according to Pharmacopoeial monographs (USP, BP, Eu.Ph, JP)
- tests of different dosage forms based on STD submitted by the clients, accompanying certifications, in-house and validated methods
- drug bioequivalance studies, as well as pharmacokinetic assays
- development of new and existing analytical methods and their further validation (using available analytical instruments).
DRUG QUALITY AND BIOEQUIVALENCE ANALYSES DEPARTMENT PROVIDES
- a complete report about developed and validated method, validation plan, validation proposal
- 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
- 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 friability
- Sotax, Switzerland - device determining disintegration
- Sotax, Switzerland - device determining 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.
