8 (812) 294-82-04 info@csuas.ru
Валидированные методы

Валидированные методы


Разработка и валидация биоаналитических методик проводится в соответствии с требованиями ФГБУ «НЦЭСМП» Минздрава России, Евразийского экономического союза, FDA и EMA. Под вашу задачу может быть разработана высокочувствительная аналитическая методика, отвечающая требованиям протокола клинического исследования.

Compound

(Metabolite, Biomarker)

Matrix

Method

LLOQ

Status*

Abacavir

Plasma

LC-MS/MS

50 ng/mL

Active

Abacavir/

Lamivudine

Plasma

LC-MS/MS

50 ng/mL

50 ng/mL

Active

Abiraterone

Plasma

LC-MS/MS

0.2 ng/mL

Active

Acetaldehyde

Plasma

LC-MS/MS

10

ng/mL

Active

Acetaminophen /

Chlorpheniramine

Plasma

LC-MS/MS

10 ng/mL

0.1 ng/mL

Active

Acetaminophen /

Caffeine

Plasma

LC-MS/MS

10 ng/mL

100 ng/mL

Active

Acetylsalicylic acid /

Salicylic acid

Plasma

LC-MS/MS

4 ng/mL

15 ng/mL

Active

Acotiamide

Plasma

LC-MS/MS

0.5 ng/ml

Active

Ademethionine

Plasma

LC-MS/MS

10 ng/mL

Active

Ambroxol

Plasma

LC-MS/MS

1 ng/mL

Active

Ambroxol /

Cetirizine

Plasma

LC-MS/MS

1 ng/mL

4 ng/mL

Active

p-Aminosalicylic acid

Plasma

LC-MS/MS

50 ng/mL

Active

Amlodipine

Plasma

LC-MS/MS

0.2 ng/mL

Active

Amlodipine /

Metoprolol

Plasma

LC-MS/MS

0.2 ng/mL

0.1 ng/mL

Active

Amlodipine /

Telmisartan

Plasma

LC-MS/MS

0.2 ng/mL

2.5 ng/mL

Active

Amoxicilline /

Clavulanic acid

Plasma

LC-MS/MS

100 ng/mL

50 ng/mL

Active

Anagrelide

Plasma

LC-MS/MS

50 pg/mL

Active

Anandamide

Plasma

LC-MS/MS

0.1 ng/mL

Active

2-Arachidonoyl glycerol

Plasma

LC-MS/MS

0.5 ng/mL

Active

Arginine

Plasma

LC-MS/MS

4 µg/mL

Active

Atazanavir

Plasma

LC-MS/MS

5 ng/mL

Active

Atorvastatin

Plasma

LC-MS/MS

0.2 ng/mL

Active

Atorvastatin / Valsartan

Plasma

LC-MS/MS

0.2 ng/mL

10 ng/ml

Active

Azacitidine

Plasma

LC-MS/MS

3 ng/ml

Active

Bosentan

Plasma

LC-MS/MS

5 ng/mL

Active

Bicalutamide

Plasma

LC-MS/MS

10 ng/mL

Active

Bisoprolol

Plasma

LC-MS/MS

0.5 ng/mL

Active

Buspirone / 6-Hydroxy buspirone / 2-(1-Piperazinyl)pyrimidine (1-PP)

Plasma

LC-MS/MS

20/50pg/mL

0.5 ng/mL

Active

Capecitabine /

5-Fluorouracil

Plasma

LC-MS/MS

20 ng/mL

20 ng/mL

Active

Celecoxib

Plasma

LC-MS/MS

10 ng/mL

Active

Cetirizine (Levocetirizine)

Plasma

LC-MS/MS

1 ng/mL

Active

Chlorpromazine

Plasma

LC-MS/MS

1 ng/mL

Active

Choline

Plasma

LC-MS/MS

50 ng/mL

Active

Cinacalcet

Plasma

LC-MS/MS

0.1 ng/mL

0.05 ng/mL

Active

Cisplatine

Plasma

LC-MS/MS

1 ng/mL

Active

Citalopram

Plasma

LC-MS/MS

0.3 ng/mL

Active

Clopidogrel / Carboxylic acid Clopidogrel

Plasma

LC-MS/MS

10 pg/ml

100 ng/mL

Active

Coenzyme Q10 /

reduced Coenzyme Q10 (ubiquinol)/

Coenzyme Q9

Plasma

Tissue

LC-MS/MS

1 µg/mL

Active

Corticosterone

Urine

LC-MS/MS

5 ng/mL

Active

Cortineff

Urine

LC-MS/MS

1 ng/mL

Inactive

Cortisol (6ß-Hydroxycortisol)

Urine

LC-MS/MS

5 ng/mL

Active

Cortisone

Urine

LC-MS/MS

5 ng/mL

Active

Creamide

Plasma

LC-MS/MS

0.1 µg/mL

Active

Cycloserine

Plasma

LC-MS/MS

0.3 µg/mL

Active

Dabigatran free/total

Plasma

LC-MS/MS

0.5 ng/mL

Active

Dapoxetine

Plasma

LC-MS/MS

1 ng/mL

Active

Darunavir

Plasma

LC-MS/MS

50 ng/mL

Active

Dasatinib

Plasma

LC-MS/MS

1 ng/mL

Active

Desloratadin

Plasma

LC-MS/MS

50 pg/ml

Active

Dexamethasone

Urine

LC-MS/MS

1 ng/mL

Active

Dexketoprofen

Plasma

LC-MS/MS

50 ng/mL

Active

Diclofenac / Tolperisone

Plasma

LC-MS/MS

50 ng/mL

0.5 ng/mL

Active

Docetaxel

Plasma

LC-MS/MS

2 ng/mL

Active

Dopamine

Plasma

Urine

HPLC/ED

0.35 ng/mL

Active

Doxazosin

Plasma

LC-MS/MS

0.3 ng/mL

Active

Doxepin / N-Desmethyldoxepin

Plasma

LC-MS/MS

100 pg/ml

100 pg/ml

Active

Doxorubicin

Plasma

Tissue

LC-MS/MS

0.5 ng/mL

Active

Doxylamine

Plasma

LC-MS/MS

0.2 ng/mL

Active

Drospirenone

Plasma

LC-MS/MS

0.2 ng/mL

Active

Dutasteride /

Tamsulosin

Plasma

LC-MS/MS

0.1/

0.2 ng/mL

Active

Ebastine

Carebastin

Plasma

LC-MS/MS

Development

Efavirenz

Plasma

LC-MS/MS

100 ng/mL

Active

Emtricitabine

Plasma

LC-MS/MS

20 ng/mL

Active

Emtricitabine /

Tenofovir

Plasma

LC-MS/MS

10 ng/mL

4 ng/mL

Active

Enalapril

Plasma

LC-MS/MS

0.5 ng/mL

Active

Entecavir

Plasma

LC-MS/MS

0.1 ng/mL

Active

Epinephrine

Plasma

Urine

HPLC/ED

0.2 ng/mL

Active

Eplerenone

Plasma

LC-MS/MS

25 ng/mL

Active

Estradiol (Unconjugated) /

Estrone (Unconjugated)

Plasma

LC-MS/MS

3 pg/ml /

8 pg/ml

Active

Estrone (Totall)

Plasma

LC-MS/MS

0.1 ng/mL

Pre-Active

Eremomycin

Plasma

LC-MS/MS

50 ng/mL

Active

Esomeprazole

Plasma

LC-MS/MS

1 ng/mL

Active

Ethinyl Estradiol

Plasma

LC-MS/MS

3 pg/ml

Active

Ethyl lysine

Plasma

LC-MS/MS

20 ng/mL

Active

Etoricoxib

Plasma

LC-MS/MS

10 ng/mL

Active

Ezetimibe / Ezetimibe Glucuronide

Plasma

LC-MS/MS

0.1 ng/mL

1 ng/mL

Active

Febuxostat

Plasma

LC-MS/MS

50 ng/mL

Active

Fexofenadine

Plasma

LC-MS/MS

1 ng/mL

Active

Finasteride

Plasma

LC-MS/MS

0.5 ng/mL

Active

Fingolimod ( FTY720 )/

Fingolimod phosphate ( FTY720-P)

Blood

LC-MS/MS

50 pg/mL

70 pg/mL

Active

Fingolimod ( FTY720 )

Blood

LC-MS/MS

20 pg/mL

Active

Fosfomycin

Plasma

LC-MS/MS

1 mkg/ml

Active

Furazidin

Plasma

LC-MS/MS

-

Development

Gliclazide

Plasma

LC-MS/MS

20 ng/mL

Active

Homovanillic acid

Urine

HPLC/ED

10 ng/mL

Active

Ibandronic Acid

Plasma

LC-MS/MS

0.8 ng/mL

Active

Ibuprofen

Plasma

LC-MS/MS

200 ng/mL

Active

Imatinib

Plasma

LC-MS/MS

5 ng/mL

Active

Inosine / Methionine /

Nicotinamide

Plasma

LC-MS/MS

1/3 mkg/ml

200 ng/ml

Active

Irbesartan

Plasma

LC-MS/MS

5 ng/mL

Active

Itopride

Plasma

LC-MS/MS

5 ng/mL

Active

Ketorolac

Plasma

LC-MS/MS

10 ng/mL

Active

Kynurenine

Plasma

HPLC/UV

10 ng/mL

Inactive

Kynurenic acid

Plasma

HPLC/UV

20 ng/mL

Inactive

Lamotrigine

Plasma

LC-MS/MS

10 ng/mL

Active

Lenalidomide

Plasma

LC-MS/MS

1 ng/mL

Active

Lercanidipine

Plasma

LC-MS/MS

50 pg/ml

Active

Levetiracetam

Plasma

LC-MS/MS

200 ng/mL

Active

Levofloxacin

Plasma

LC-MS/MS

250 ng/mL

Active

Levonorgestrel

Plasma

LC-MS/MS

0.1 ng/mL

Active

Lidocaine

Plasma

LC-MS/MS

1 ng/mL

Active

Linezolid

Plasma

LC-MS/MS

100 ng/mL

Active

Lipoic acid

Plasma

LC-MS/MS

5 ng/mL

Active

Lisinopril

Plasma

LC-MS/MS

5 ng/mL

Active

Losartan

Plasma

LC-MS/MS

5 ng/mL

Active

Losartan / Hydrochlorothiazide

Plasma

LC-MS/MS

1.5 ng/mL

1 ng/mL

Active

Marcaine

Plasma

Tissue

LC-MS/MS HPLC/UV

1 ng/mL

Active

Mebeverin Acid/

o-desmethyl mebeverine acid

Plasma

LC-MS/MS

1 ng/mL

5 ng/mL

Active

Melatonin

Plasma

LC-MS/MS

10 pg/ml

Active

Meloxicam

Plasma

LC-MS/MS

10 ng/mL

Active

Melphalan

Plasma

Tissue

LC-MS/MS

0.3 ng/mL

Active

Memantine

Plasma

LC-MS/MS

0.3 ng/mL

Active

Metanephrine

Urine

HPLC/ED

10 ng/mL

Active

Metformin / Sitagliptin

Plasma

LC-MS/MS

10 ng/mL

1 ng/mL

Active

Metoprolol

Plasma

LC-MS/MS

0.1 ng/mL

Active

Mexidol (Emoxypine)

Plasma

LC-MS/MS

0.5 ng/mL

Active

Mildronate

Plasma

LC-MS/MS

50 ng/mL

Active

4-Methylaminoantipyrine (Metamizole metabolite)

Plasma

LC-MS/MS

100 ng/mL

Active

Mitomicyn C

Plasma

Tissue

LC-MS/MS

0.6 ng/mL

Active

Mitotane

Plasma

HPLC-UV

0.75 mkg/mL

Active

Mitoxantrone

Plasma

Tissue

LC-MS/MS

5 ng/mL

Inactive

Monomethyl fumarate

Plasma

LC-MS/MS

10 ng/mL

Active

Montelukast/

Cetirizine

Plasma

LC-MS/MS

10 ng/mL

1 ng/mL

Active

Moxifloxacin

Plasma

LC-MS/MS

2 ng/mL

Active

Moxonidine

Plasma

LC-MS/MS

50 pg/mL

Active

Naftidrofuryl

Plasma

LC-MS/MS

10 ng/mL

Active

Naloxone

Plasma

LC-MS/MS

80 pg/mL

Active

Naltrexone

Plasma

LC-MS/MS

150 pg/mL

Active

Nevirapine

Plasma

LC-MS/MS

80 ng/mL

Active

Nifedipine/

Lidocaine

Plasma

LC-MS/MS

0.5 ng/mL

1 ng/mL

Active

Nilotinib

Plasma

LC-MS/MS

2 ng/mL

Active

Nimesulide

Plasma

LC-MS/MS

20 ng/mL

Active

Nitisinone

Plasma

LC-MS/MS

5 ng/mL

Active

Norepinephrine

Plasma

Urine

HPLC/ED

0.2 ng/mL

Active

Normetanephrine

Urine

HPLC/ED

5 ng/mL

Active

Oxybutynin

Plasma

Tissue

LC-MS/MS

0.5 ng/mL

Active

Oseltamivir carboxylate

Plasma

LC-MS/MS

2 ng/mL

Active

PAS (4-Aminosalicylic acid)

Plasma

LC-MS/MS

50 ng/mL

Active

Pazopanib

Plasma

LC-MS/MS

300 ng/mL

Active

Penciclovir

Plasma

LC-MS/MS

50 ng/mL

Active

Perindopril /

Perindoprilat

Plasma

LC-MS/MS

0.4 ng/mL

0.4 ng/mL

Active

Perindoprilat /

Indapamide

Plasma

LC-MS/MS

0.4 ng/mL

0.3 ng/mL

Active

Phenibut

Plasma

LC-MS/MS

10 ng/mL

Active

Phenylephrine

Plasma

LC-MS/MS

30 pg/ml

Active

Pirfenidone

Plasma

LC-MS/MS

5 ng/mL

Active

Pregabalin

Plasma

LC-MS/MS

50 ng/mL

Active

Rabeprazole

Plasma

LC-MS/MS

2 ng/mL

Active

Ranolazine

Plasma

LC-MS/MS

5 ng/mL

Active

Ramipril /

Ramiprilat

Plasma

LC-MS/MS

0.2 ng/mL

0.5 ng/mL

Active

Ritonavir

Plasma

LC-MS/MS

5 ng/mL

Active

Rivaroxaban

Plasma

LC-MS/MS

0.5 ng/mL

Active

Rhein (Diacerein)

Plasma

HPLC/UV

100 ng/mL

Active

Ropinipole

Plasma

LC-MS/MS

10 pg/mL

Active

Rosuvastatin

Plasma

LC-MS/MS

0.2 ng/mL

Active

Salbutamol

Plasma

LC-MS/MS

0.2 ng/mL

Active

Serotonin

Plasma

HPLC/UV

10 ng/mL

Active

Sildenafil

Plasma

LC- MS/MS

5 ng/mL

Active

Sildenafil

Plasma

LC-MS/MS

1 ng/mL

Active

Sitagliptin

Plasma

LC-MS/MS

1 ng/mL

Active

Solifenacin

Plasma

LC-MS/MS

0.5 ng/mL

Active

Spironolactone /

Canrenone

Plasma

LC-MS/MS

2 ng/mL

2 ng/mL

Active

Stavudine

Plasma

LC-MS/MS

30 ng/mL

Active

Succinic acid

Plasma

LC-MS/MS

0.1 µg/mL

Active

Sunitinib

Plasma

LC-MS/MS

-

Development

Tadalafil

Plasma

LC-MS/MS

5 ng/ml

Active

Tacrolimus

Blood

LC-MS/MS

0.5 ng/mL

0.1 ng/mL

Active

Active

Tamsulosin

Plasma

LC-MS/MS

0.1 ng/mL

Active

Telmisartan

Plasma

LC-MS/MS

3 ng/mL

Active

Telmisartan/

Hydrochlorothiazide

Plasma

LC-MS/MS

3 ng/mL

1 ng/mL

Active

Tenofovir

Plasma

LC-MS/MS

4 ng/mL

Active

Terbinafine

Plasma

LC-MS/MS

1 ng/mL

Active

Terizidone

Plasma

LC-MS/MS

0.3 µg/mL

Active

Thyroxine (T4)

Serum

LC-MS/MS

30 ng/mL

Active

Ticagrelor / AR-C124910XX

Plasma

LC-MS/MS

5 ng/mL/

2.5 ng/mL

Active

Tilorone

Plasma

LC-MS/MS

0.5 ng/mL

Active

Tolperisone

Plasma

LC-MS/MS

0.5 ng/mL

Active

Troventol

Plasma

LC-MS/MS

35 pg/mL

Active

Troxerutin

Plasma

LC-MS/MS

20 pg/ml

Active

Tryptophan

Plasma

HPLC/UV

10 ng/mL

Active

Quetiapine

Plasma

LC-MS/MS

1 ng/mL

Active

Ursodeoxycholic acid

Plasma

LC-MS/MS

50 ng/mL

Active

Valsartan

Plasma

LC-MS/MS

10 ng/mL

Active

Vanillyl mandelic acid

Urine

HPLC/UV

10 ng/mL

Active

Vildagliptin / Metformin

Plasma

LC-MS/MS

2 ng/mL

5 ng/mL

Active

Vinblastine

Plasma

Tissue

LC-MS/MS HPLC/UV

1 ng/mL

Active

Voriconazole

Plasma

LC-MS/MS

20 ng/mL

Active

Warfarin

Plasma

LC-MS/MS

5 ng/mL

Active

Zidovudine

Plasma

LC-MS/MS

40 ng/mL

Active

Zidovudine /

Lamivudine

Plasma

LC-MS/MS

30 ng/mL

25 ng/mL

Active

Полный перечень валидированных методик

Контакты

Наш адрес:


194156, Санкт-Петербург,
пр. Энгельса, д. 34, литера В, оф. 202

Тел.:

8 (812) 294-82-04

Факс:

8 (812) 294-82-04

E-mail:

info@csuas.ru
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