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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
Metabolism studies

- CYP P450 System Inhibition

- Stability in plasma/microsomes/s9

- Identification of metabolites

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
orto-hydroxy-atorvastatine

0.5
0.5

ng/ml

Human plasma

LC-MS/MS

Atorvastatine
Perindopril
Perindoprilat

0.25
0.5
0.1

ng/ml

Human plasma

LC-MS/MS

Azythromycin

3

ng/ml

Human plasma

LC-MS/MS

Bisoprolol
Perindopril
Perindoprilat

0.5
1
0.2

ng/ml

Human plasma

LC-MS/MS

Buspirone
6-OH-Busp
1PP

0.01
0.05
0.05

ng/ml

Human plasma

LC-MS/MS

Capecitabine
5-FU

20
12

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
HCTZ

1
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)
Rosuvastatin

0.04
0.2

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
5

ng/ml

Human plasma

LC-MS/MS

Fingolimod
P-Fingolimod

0.05
0.1

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
100

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
HCTZ

10
1

ng/ml

Human plasma

LC-MS/MS

Isoprinosine A-PABA
Isoprinosine DIP

20
20

ng/ml

Human plasma

LC-MS/MS

Ivabradine

0.05

ng/ml

Human plasma

LC-MS/MS

Ivabradine 
Metoprolol

0.05
0.1

ng/ml

Human plasma

LC-MS/MS

Lamivudine

10

ng/ml

Human plasma

LC-MS/MS

Lamivudine
Zidovudine

7.5/7.50
15/15

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
25
100

ng/ml

Human plasma

LC-MS/MS

Losartan

2

ng/ml

Human plasma

LC-MS/MS

Losartan
Amlodipin
Rosuvastatin

2
0.1
0.1

ng/ml

Human plasma

LC-MS/MS

Losartan
E-3174

4.68
5

ng/ml

Human plasma

LC-MS/MS

Losartan
E-3174 (metabolite)
HCTZ

1
2
0.5

mME/ml

Human plasma

LC-MS/MS

Losartan
HCTZ

2
0.5

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
Melatonine

0.2
0.05

ng/ml

Human plasma

LC-MS/MS

Metformin

10

ng/ml

Human plasma

LC-MS/MS

Metformin
Glibenclamide

20
2

ng/ml

Human plasma

LC-MS/MS

Metformin
Glimepiride

20
2

ng/ml

Human plasma

LC-MS/MS

Mexidol

0.5

ng/ml

Human plasma

LC-MS/MS

Mexidol (metabolite)

1
10

ng/ml

Human plasma

LC-MS/MS

Monomethylfumarate

1

ng/ml

Human plasma

LC-MS/MS

Montelukast
Levocetirizine

10
1

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
HCTZ

10
0.9

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
50

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/ml
Матрица
Human plasma
Метод
LC-MS/MS

Ambroxol

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Amlodipine

НПКО

0.1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Apixaban

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Atazanavir 

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Atorvastatine

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Atorvastatine
orto-hydroxy-atorvastatine

НПКО

0.5
0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Atorvastatine
Perindopril
Perindoprilat

НПКО

0.25
0.5
0.1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Azythromycin

НПКО

3

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Bisoprolol
Perindopril
Perindoprilat

НПКО

0.5
1
0.2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Buspirone
6-OH-Busp
1PP

НПКО

0.01
0.05
0.05

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Capecitabine
5-FU

НПКО

20
12

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Cholecalciferol

НПКО

0.25

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Dabigatran

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Dapoxetin

НПКО

5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Darunavir

НПКО

100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Desloratadine

НПКО

0.05

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Diclofenac

НПКО

100

Ед.изм
ng/ml
Матрица
Human Plasma
Метод
LC-MS/MS

Digoxin

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Doxylamine

НПКО

0.4

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Duloxetine

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Enalapril

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Enalapril
HCTZ

НПКО

1
1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Enrofloxacin

НПКО

20000 

Ед.изм
ng/ml
Матрица
Feed
Метод
LC-MS/MS

Eplerenone

НПКО

5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Escitalopram

НПКО

0.25

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LS-MS/MS

Etoricoxib

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Ezetimibe (free)
Rosuvastatin

НПКО

0.04
0.2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Ezetimibe (total)

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

FSH

НПКО

5

Ед.изм
mMU/ml
Матрица
Human serum
Метод
ELISA

Febuxostat

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Fenspiride

НПКО

1
5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Fingolimod
P-Fingolimod

НПКО

0.05
0.1

Ед.изм
ng/ml
Матрица
Human blood
Метод
LC-MS/MS

Florfenicol

НПКО

20

Ед.изм
ng/ml
Матрица
Feed
Метод
LC-MS/MS

Fluconazole

НПКО

50

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Flupirtin

НПКО

3

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Galantamine

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Gefitinib

НПКО

0.3

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Gliklazide

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Heparine (anti-FIIa activity)

НПКО

0.156

Ед.изм
ME/ml
Матрица
Human plasma
Метод
ELISA

Ibuprofen

НПКО

500
100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Imatinib

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Indapamide

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Insulin

НПКО

0.75

Ед.изм
mME/ml
Матрица
Human serum
Метод
ELISA

Irbesartan
HCTZ

НПКО

10
1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Isoprinosine A-PABA
Isoprinosine DIP

НПКО

20
20

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Ivabradine

НПКО

0.05

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Ivabradine 
Metoprolol

НПКО

0.05
0.1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Lamivudine

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Lamivudine
Zidovudine

НПКО

7.5/7.50
15/15

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Levitiracetam

НПКО

0.1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Levofloxacin

НПКО

100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Linalidamide

НПКО

2
25
100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Losartan

НПКО

2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Losartan
Amlodipin
Rosuvastatin

НПКО

2
0.1
0.1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Losartan
E-3174

НПКО

4.68
5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Losartan
E-3174 (metabolite)
HCTZ

НПКО

1
2
0.5

Ед.изм
mME/ml
Матрица
Human plasma
Метод
LC-MS/MS

Losartan
HCTZ

НПКО

2
0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Meloxicam

НПКО

0.05

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Memantine

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Memantine
Melatonine

НПКО

0.2
0.05

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Metformin

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Metformin
Glibenclamide

НПКО

20
2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Metformin
Glimepiride

НПКО

20
2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Mexidol

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Mexidol (metabolite)

НПКО

1
10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Monomethylfumarate

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Montelukast
Levocetirizine

НПКО

10
1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Moxifloxacin

НПКО

25

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Nilotinib

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Oseltamivir

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

PASK

НПКО

100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Pantoprazole

НПКО

22

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Periziazine

НПКО

0.15

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Phenibut

НПКО

100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Phenylpiracetam

НПКО

10

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Pitavastatine

НПКО

0.2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Prasugrel active metabolite (R-138727)

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Prasugrel inactive metabolite (R-95913)

НПКО

0.25

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Quetiapine

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Sildenafil

НПКО

2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Solifenacine

НПКО

0.1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Sorafenib

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Sotalol

НПКО

20

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Sumatriptane

НПКО

0.2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Sunitinib

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Telmisartan
HCTZ

НПКО

10
0.9

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Temozolomide

НПКО

100

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Teriflunomide

НПКО

40

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Ticagrelor

НПКО

5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Tilorone

НПКО

1

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Tolperisone

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Torasemide

НПКО

10
50

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Trimetazidine

НПКО

0.5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Valganciclovir

НПКО

5

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Valproic acid

НПКО

1000

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Vildagliptine

НПКО

2

Ед.изм
ng/ml
Матрица
Human plasma
Метод
LC-MS/MS

Vincristine

НПКО

1

Ед.изм
ng/ml
Матрица
Rat plasma
Метод
LC-MS/MS