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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
Amiodarone
Plasma
LC-MS/MS
3 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 /
Perindopril
Plasma
LC-MS/MS
0.1 ng/mL
0.5 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
Apixaban
Plasma
LC-MS/MS
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
Atenolol
Plasma
LC-MS/MS
3 ng/mL
Active
Atorvastatin
Plasma
LC-MS/MS
0.2 ng/mL
Active
Atorvastatin /
ortho-Hydroxy Atorvastatin /
para-Hydroxy Atorvastatin
Plasma
LC-MS/MS
100 pg/mL
100 pg/mL
10 pg/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
Azithromycin
Plasma
LC-MS/MS
1 ng/ml
Active
Baclofen
Plasma
LC-MS/MS
5 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
100 ng/mL
Active
Cilostazol
Plasma
LC-MS/MS
5 ng/mL
Active
Cinacalcet
Plasma
LC-MS/MS
0.1 ng/mL
0.05 ng/mL
Active
Ciprofloxacin
Plasma
LC-MS/MS
50 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
Deferasirox
Plasma
LC-MS/MS
0.05 µg/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
Diazoxide
Plasma
LC-MS/MS
20 ng/mL
Active
Diphenhydramine
Plasma
LC-MS/MS
0.5 ng/mL
Active
Diclofenac
Plasma
LC-MS/MS
5 ng/mL
Active
Diclofenac /
Tolperisone
Plasma
LC-MS/MS
0.5 ng/mL
Active
Diosmetin /
Hesperetin
Plasma
LC-MS/MS
1 ng/mL
1 ng/mL
Active
4-Dimethylaminopheno
Plasma
LC-MS/MS
1 ng/mL
Active
Docetaxel
Plasma
LC-MS/MS
2 ng/mL
Active
Dolutegravir
Plasma
LC-MS/MS
10 ng/mL
Active
Domperidone
Plasma
LC-MS/MS
0.2 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
0.25 ng/mL
Active
Dutasteride /
Tamsulosin
Plasma
LC-MS/MS
0.1/
0.2 ng/mL
Active
Ebastine /
Carebastine
Plasma
LC-MS/MS
    1. ng/ml
1 ng/ml
Active
Efavirenz
Plasma
LC-MS/MS
100 ng/mL
Active
Eltrombopag
Plasma
LC-MS/MS
20 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
Eremomycin
Plasma
LC-MS/MS
50 ng/mL
Active
Estradiol (Unconjugated) /
Estrone (Unconjugated)
Plasma
LC-MS/MS
5 pg/ml /
10 pg/ml
Active
Estrone (Total)
Plasma
LC-MS/MS
15 pg/mL
Active
Esomeprazole
Plasma
LC-MS/MS
1 ng/mL
Active
Ethinyl Estradiol
Plasma
LC-MS/MS
1 pg/ml
Active
Ethyl lysine
Plasma
LC-MS/MS
20 ng/mL
Active
Etonogestrel
Plasma
LC-MS/MS
50 pg/mL
Active
Etoricoxib
Plasma
LC-MS/MS
10 ng/mL
Active
Everolimus
Blood
LC-MS/MS
1 ng/ml
Active
Ezetimibe /
Ezetimibe Glucuronide
Plasma
LC-MS/MS
    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
Fluvoxamine
Plasma
LC-MS/MS
0.25 ng/mL
Active
Fosfomycin
Plasma
LC-MS/MS
1 mkg/ml
Active
Furazidin
Plasma
LC-MS/MS
3 ng/ml
Active
Gidazepam
Desalkylgidazepam
Plasma
LC-MS/MS
10 ng/ml
4 ng/ml
Active
Gliclazide
Plasma
LC-MS/MS
20 ng/mL
Active
Glimepiride
Plasma
LC-MS/MS
1 ng/mL
Active
Homovanillic acid
Urine
HPLC/ED
10 ng/mL
Active
N-Hydroxycytidine (Molnupiravir metabolite)
Plasma
LC-MS/MS
1 ng/mL
Active
Ibandronic Acid
Plasma
LC-MS/MS
0.8 ng/mL
Active
Ibuprofen
Plasma
LC-MS/MS
200 ng/mL
Active
Indapamide
Plasma
LC-MS/MS
0.5 ng/mL
Active
Indapamide
Blood
LC-MS/MS
0.5 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
Ivabradine
Plasma
LC-MS/MS
0.5 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
Loxoprofen
Plasma
LC-MS/MS
50 ng/mL
Active
Lysine /
Acridone acetic acid
Plasma
LC-MS/MS
1.5 μg/mL
0.3 μg/mL
Active
Macitentan
Plasma
LC-MS/MS
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
Meglumine /
Acridone acetic acid
Plasma
LC-MS/MS
0.5 μg/mL
0.05 μg/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
Miglustat
Plasma
LC-MS/MS
10 ng/mL
Active
Mildronate
Plasma
LC-MS/MS
50 ng/mL
Active
Mirtazapine /
Tizanidine
Plasma
LC-MS/MS
1 ng/mL
0.2 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
Nefopam
Plasma
LC-MS/MS
0.5 ng/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
2,2′,2′′-Nitrilotriethanol
Plasma
LC-MS/MS
20 ng/ml
Active
Norepinephrine
Plasma
Urine
HPLC/ED
0.2 ng/mL
Active
Normetanephrine
Urine
HPLC/ED
5 ng/mL
Active
Obeticholic acid
Plasma
LC-MS/MS
1 ng/ml
Active
Oxybutynin
Plasma
Tissue
LC-MS/MS
0.5 ng/mL
Active
Oseltamivir /
Oseltamivir carboxylate
Plasma
LC-MS/MS
0.5 ng/mL
1 ng/ml
Active
Oseltamivir carboxylate
Plasma
LC-MS/MS
2 ng/mL
Active
Paliperidone
Plasma
LC-MS/MS
0.3 ng/mL
Active
PAS (4-Aminosalicylic acid)
Plasma
LC-MS/MS
50 ng/mL
Active
Pantoprazole
Plasma
LC-MS/MS
5 ng/mL
Active
Paroxetine
Plasma
LC-MS/MS
0.1 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
Pomalidomide
Plasma
LC-MS/MS
1 ng/ml
Active
Posaconazole
Plasma
LC-MS/MS
5 ng/mL
Active
Praziquantel
Plasma
LC-MS/MS
1.5 ng/ml
Active
Pregabalin
Plasma
LC-MS/MS
50 ng/mL
Active
Rabeprazole
Plasma
LC-MS/MS
2 ng/mL
Active
Rankvilon (GB-115)
Plasma
LC-MS/MS
0.2 ng/mL
Active
Rankvilon (GB-115)
Urine
LC-MS/MS
0.5 ng/mL
Active
Rankvilon (GB-115)
Tissues (liver, kidney, omen-tum, brain, muscle)Fecal
LC-MS/MS
2 ng/g
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
Rimantadine
Plasma
LC-MS/MS
0.5 ng/mL
Active
Ritonavir
Plasma
LC-MS/MS
5 ng/mL
Active
Ritonavir /
Lopinavir
Plasma
LC-MS/MS
1 ng/mL
5 ng/mL
Active
Rivaroxaban
Plasma
LC-MS/MS
0.5 ng/mL
Active
Rivastigmine
Plasma
LC-MS/MS
0.4 ng/mL
Active
Rizatriptan
Plasma
LC-MS/MS
0.2 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
Saxagliptin
Plasma
LC-MS/MS
0.5 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
Sumatriptan
Plasma
LC-MS/MS
0.5 ng/mL
Active
Sunitinib
Plasma
LC-MS/MS
0.3 ng/mL
Active
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
Torasemide
Plasma
LC-MS/MS
2 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
Umifenovir
Plasma
LC-MS/MS
1 ng/mL
Active
Ursodeoxycholic acid
Plasma
LC-MS/MS
50 ng/mL
Active
Uridine
Plasma
LC-MS/MS
150 ng/mL
Active
Valsartan
Plasma
LC-MS/MS
10 ng/mL
Active
Valsartan /
Hydrochlorothiazide
Plasma
LC-MS/MS
20 ng/mL
1 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
Zonisamide
Blood
LC-MS/MS
10 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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