Bioanalytical laboratory
Exacte Labs bioanalytical laboratory took part in more than three hundred drugs bioequivalence and pharmacokinetics studies. The laboratory is equipped by 5 tandem mass-spectrometers, which allow high-precision determination of low molecular weight compounds in biological samples.
The quality management system is certified in accordance with ISO 9001: 2015 and GLP.
Services
Development and validation of Bioanalytical methods
The development and validation of bioanalytical methods for the quantitative determination of drugs in various biological matrices is carried out in accordance with current recommendations.
Achievable limit of quantitative determination - from 1 pg / ml.
Result: quantitative
Method: LC-MS/MS, ELISA
Analysis of concentration in various matrixes
Quantitative determination of low molecular weight drugs by LC-MS/MS, as well as biotechnological drugs by ELISA.
Result: quantitative
Method: LC-MS/MS, ELISA
ADME studies
Drug solubility
(Shake-flask, Millipore solubility assay)
- Permeability through lipid layers (PAMPA / BAMPA)
- Plasma Protein Binding (PPB)
Result: quantitative
Method: LC-MS/MS, HPLC/UV
Data analysis
Calculation and construction of pharmacokinetic curves, statistical data processing using licensed Phoenix® WinNonlin® software.
Bioanalytical methods
| Analyte | LLOQ | Units | Matrix | Method |
|---|---|---|---|---|
Aceclofenac | 100 | ng/ml | Human plasma | LC-MS/MS |
Ambroxol | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Amlodipine | 0.1 | ng/ml | Human plasma | LC-MS/MS |
Apixaban | 1 | ng/ml | Human plasma | LC-MS/MS |
Atazanavir | 1 | ng/ml | Human plasma | LC-MS/MS |
Atorvastatine | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Atorvastatine | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Atorvastatine | 0.25 | ng/ml | Human plasma | LC-MS/MS |
Azythromycin | 3 | ng/ml | Human plasma | LC-MS/MS |
Bisoprolol | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Buspirone | 0.01 | ng/ml | Human plasma | LC-MS/MS |
Capecitabine | 20 | ng/ml | Human plasma | LC-MS/MS |
Cholecalciferol | 0.25 | ng/ml | Human plasma | LC-MS/MS |
Dabigatran | 1 | ng/ml | Human plasma | LC-MS/MS |
Dapoxetin | 5 | ng/ml | Human plasma | LC-MS/MS |
Darunavir | 100 | ng/ml | Human plasma | LC-MS/MS |
Desloratadine | 0.05 | ng/ml | Human plasma | LC-MS/MS |
Diclofenac | 100 | ng/ml | Human Plasma | LC-MS/MS |
Digoxin | 10 | ng/ml | Human plasma | LC-MS/MS |
Doxylamine | 0.4 | ng/ml | Human plasma | LC-MS/MS |
Duloxetine | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Enalapril | 1 | ng/ml | Human plasma | LC-MS/MS |
Enalapril | 1 | ng/ml | Human plasma | LC-MS/MS |
Enrofloxacin | 20000 | ng/ml | Feed | LC-MS/MS |
Eplerenone | 5 | ng/ml | Human plasma | LC-MS/MS |
Escitalopram | 0.25 | ng/ml | Human plasma | LS-MS/MS |
Etoricoxib | 10 | ng/ml | Human plasma | LC-MS/MS |
Ezetimibe (free) | 0.04 | ng/ml | Human plasma | LC-MS/MS |
Ezetimibe (total) | 1 | ng/ml | Human plasma | LC-MS/MS |
FSH | 5 | mMU/ml | Human serum | ELISA |
Febuxostat | 10 | ng/ml | Human plasma | LC-MS/MS |
Fenspiride | 1 | ng/ml | Human plasma | LC-MS/MS |
Fingolimod | 0.05 | ng/ml | Human blood | LC-MS/MS |
Florfenicol | 20 | ng/ml | Feed | LC-MS/MS |
Fluconazole | 50 | ng/ml | Human plasma | LC-MS/MS |
Flupirtin | 3 | ng/ml | Human plasma | LC-MS/MS |
Galantamine | 1 | ng/ml | Human plasma | LC-MS/MS |
Gefitinib | 0.3 | ng/ml | Human plasma | LC-MS/MS |
Gliklazide | 10 | ng/ml | Human plasma | LC-MS/MS |
Heparine (anti-FIIa activity) | 0.156 | ME/ml | Human plasma | ELISA |
Ibuprofen | 500 | ng/ml | Human plasma | LC-MS/MS |
Imatinib | 10 | ng/ml | Human plasma | LC-MS/MS |
Indapamide | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Insulin | 0.75 | mME/ml | Human serum | ELISA |
Irbesartan | 10 | ng/ml | Human plasma | LC-MS/MS |
Isoprinosine A-PABA | 20 | ng/ml | Human plasma | LC-MS/MS |
Ivabradine | 0.05 | ng/ml | Human plasma | LC-MS/MS |
Ivabradine | 0.05 | ng/ml | Human plasma | LC-MS/MS |
Lamivudine | 10 | ng/ml | Human plasma | LC-MS/MS |
Lamivudine | 7.5/7.50 | ng/ml | Human plasma | LC-MS/MS |
Levitiracetam | 0.1 | ng/ml | Human plasma | LC-MS/MS |
Levofloxacin | 100 | ng/ml | Human plasma | LC-MS/MS |
Linalidamide | 2 | ng/ml | Human plasma | LC-MS/MS |
Losartan | 2 | ng/ml | Human plasma | LC-MS/MS |
Losartan | 2 | ng/ml | Human plasma | LC-MS/MS |
Losartan | 4.68 | ng/ml | Human plasma | LC-MS/MS |
Losartan | 1 | mME/ml | Human plasma | LC-MS/MS |
Losartan | 2 | ng/ml | Human plasma | LC-MS/MS |
Meloxicam | 0.05 | ng/ml | Human plasma | LC-MS/MS |
Memantine | 1 | ng/ml | Human plasma | LC-MS/MS |
Memantine | 0.2 | ng/ml | Human plasma | LC-MS/MS |
Metformin | 10 | ng/ml | Human plasma | LC-MS/MS |
Metformin | 20 | ng/ml | Human plasma | LC-MS/MS |
Metformin | 20 | ng/ml | Human plasma | LC-MS/MS |
Mexidol | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Mexidol (metabolite) | 1 | ng/ml | Human plasma | LC-MS/MS |
Monomethylfumarate | 1 | ng/ml | Human plasma | LC-MS/MS |
Montelukast | 10 | ng/ml | Human plasma | LC-MS/MS |
Moxifloxacin | 25 | ng/ml | Human plasma | LC-MS/MS |
Nilotinib | 1 | ng/ml | Human plasma | LC-MS/MS |
Oseltamivir | 0.5 | ng/ml | Human plasma | LC-MS/MS |
PASK | 100 | ng/ml | Human plasma | LC-MS/MS |
Pantoprazole | 22 | ng/ml | Human plasma | LC-MS/MS |
Periziazine | 0.15 | ng/ml | Human plasma | LC-MS/MS |
Phenibut | 100 | ng/ml | Human plasma | LC-MS/MS |
Phenylpiracetam | 10 | ng/ml | Human plasma | LC-MS/MS |
Pitavastatine | 0.2 | ng/ml | Human plasma | LC-MS/MS |
Prasugrel active metabolite (R-138727) | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Prasugrel inactive metabolite (R-95913) | 0.25 | ng/ml | Human plasma | LC-MS/MS |
Quetiapine | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Sildenafil | 2 | ng/ml | Human plasma | LC-MS/MS |
Solifenacine | 0.1 | ng/ml | Human plasma | LC-MS/MS |
Sorafenib | 1 | ng/ml | Human plasma | LC-MS/MS |
Sotalol | 20 | ng/ml | Human plasma | LC-MS/MS |
Sumatriptane | 0.2 | ng/ml | Human plasma | LC-MS/MS |
Sunitinib | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Telmisartan | 10 | ng/ml | Human plasma | LC-MS/MS |
Temozolomide | 100 | ng/ml | Human plasma | LC-MS/MS |
Teriflunomide | 40 | ng/ml | Human plasma | LC-MS/MS |
Ticagrelor | 5 | ng/ml | Human plasma | LC-MS/MS |
Tilorone | 1 | ng/ml | Human plasma | LC-MS/MS |
Tolperisone | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Torasemide | 10 | ng/ml | Human plasma | LC-MS/MS |
Trimetazidine | 0.5 | ng/ml | Human plasma | LC-MS/MS |
Valganciclovir | 5 | ng/ml | Human plasma | LC-MS/MS |
Valproic acid | 1000 | ng/ml | Human plasma | LC-MS/MS |
Vildagliptine | 2 | ng/ml | Human plasma | LC-MS/MS |
Vincristine | 1 | ng/ml | Rat plasma | LC-MS/MS |
Аналит
Aceclofenac
НПКО
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAmbroxol
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAmlodipine
НПКО
0.1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSApixaban
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAtazanavir
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAtorvastatine
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAtorvastatine
orto-hydroxy-atorvastatine
НПКО
0.5
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAtorvastatine
Perindopril
Perindoprilat
НПКО
0.25
0.5
0.1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSAzythromycin
НПКО
3
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSBisoprolol
Perindopril
Perindoprilat
НПКО
0.5
1
0.2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSBuspirone
6-OH-Busp
1PP
НПКО
0.01
0.05
0.05
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSCapecitabine
5-FU
НПКО
20
12
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSCholecalciferol
НПКО
0.25
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDabigatran
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDapoxetin
НПКО
5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDarunavir
НПКО
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDesloratadine
НПКО
0.05
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDiclofenac
НПКО
100
Ед.изм
ng/mlМатрица
Human PlasmaМетод
LC-MS/MSDigoxin
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDoxylamine
НПКО
0.4
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSDuloxetine
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSEnalapril
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSEnalapril
HCTZ
НПКО
1
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSEnrofloxacin
НПКО
20000
Ед.изм
ng/mlМатрица
FeedМетод
LC-MS/MSEplerenone
НПКО
5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSEscitalopram
НПКО
0.25
Ед.изм
ng/mlМатрица
Human plasmaМетод
LS-MS/MSEtoricoxib
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSEzetimibe (free)
Rosuvastatin
НПКО
0.04
0.2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSEzetimibe (total)
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSFSH
НПКО
5
Ед.изм
mMU/mlМатрица
Human serumМетод
ELISAFebuxostat
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSFenspiride
НПКО
1
5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSFingolimod
P-Fingolimod
НПКО
0.05
0.1
Ед.изм
ng/mlМатрица
Human bloodМетод
LC-MS/MSFlorfenicol
НПКО
20
Ед.изм
ng/mlМатрица
FeedМетод
LC-MS/MSFluconazole
НПКО
50
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSFlupirtin
НПКО
3
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSGalantamine
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSGefitinib
НПКО
0.3
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSGliklazide
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSHeparine (anti-FIIa activity)
НПКО
0.156
Ед.изм
ME/mlМатрица
Human plasmaМетод
ELISAIbuprofen
НПКО
500
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSImatinib
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSIndapamide
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSInsulin
НПКО
0.75
Ед.изм
mME/mlМатрица
Human serumМетод
ELISAIrbesartan
HCTZ
НПКО
10
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSIsoprinosine A-PABA
Isoprinosine DIP
НПКО
20
20
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSIvabradine
НПКО
0.05
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSIvabradine
Metoprolol
НПКО
0.05
0.1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLamivudine
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLamivudine
Zidovudine
НПКО
7.5/7.50
15/15
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLevitiracetam
НПКО
0.1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLevofloxacin
НПКО
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLinalidamide
НПКО
2
25
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLosartan
НПКО
2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLosartan
Amlodipin
Rosuvastatin
НПКО
2
0.1
0.1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLosartan
E-3174
НПКО
4.68
5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSLosartan
E-3174 (metabolite)
HCTZ
НПКО
1
2
0.5
Ед.изм
mME/mlМатрица
Human plasmaМетод
LC-MS/MSLosartan
HCTZ
НПКО
2
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMeloxicam
НПКО
0.05
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMemantine
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMemantine
Melatonine
НПКО
0.2
0.05
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMetformin
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMetformin
Glibenclamide
НПКО
20
2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMetformin
Glimepiride
НПКО
20
2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMexidol
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMexidol (metabolite)
НПКО
1
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMonomethylfumarate
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMontelukast
Levocetirizine
НПКО
10
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSMoxifloxacin
НПКО
25
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSNilotinib
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSOseltamivir
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPASK
НПКО
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPantoprazole
НПКО
22
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPeriziazine
НПКО
0.15
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPhenibut
НПКО
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPhenylpiracetam
НПКО
10
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPitavastatine
НПКО
0.2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPrasugrel active metabolite (R-138727)
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSPrasugrel inactive metabolite (R-95913)
НПКО
0.25
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSQuetiapine
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSSildenafil
НПКО
2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSSolifenacine
НПКО
0.1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSSorafenib
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSSotalol
НПКО
20
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSSumatriptane
НПКО
0.2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSSunitinib
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTelmisartan
HCTZ
НПКО
10
0.9
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTemozolomide
НПКО
100
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTeriflunomide
НПКО
40
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTicagrelor
НПКО
5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTilorone
НПКО
1
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTolperisone
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTorasemide
НПКО
10
50
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSTrimetazidine
НПКО
0.5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSValganciclovir
НПКО
5
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSValproic acid
НПКО
1000
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSVildagliptine
НПКО
2
Ед.изм
ng/mlМатрица
Human plasmaМетод
LC-MS/MSVincristine
НПКО
1
Ед.изм
ng/mlМатрица
Rat plasmaМетод
LC-MS/MS