Capabilities & Methods
Our GLP-certified laboratory has high-capacity UPLC/MSS/MS equipments. Our state-of-the-art equipment, instrumentation, and software includes the following:
Mass spectrometers
- Triple Quad 5500TM (AB Sciex)
- 6495 Triple Quad MS (Agilent)
- TQD® (Waters)
Liquid chromatography systems
- 1290 Infinity LC system (Agilent)
- 1290 Infinity II multisampler (Agilent)
- CTC PAL autosampler (CTC Analytics)
- UPLC Acquity® (Waters)
Automated 96-well sample preparation
Validated Analytical softwares (GAMP 5, 21 CFR Part 11 compliant)
- Analyst 1.6.0 (AB Sciex)
- Masshunter B.07.00 (Agilent)
- MassLynx 4.1 (Waters)
- Dynakin also provides complete services for storing reference products and biological samples. Our facility features:
- Refrigerated storage (4ºC)
- Low temperature storage (-20ºC, and -80ºC)
- Emergency back-up electrical and heating services
- An uninterrupted Power Supply unit (UPS)
- On-site archive facility with limited access, environmentally controlled.
CYTOSTATIC DRUGS: VALIDATED BIONALYTICAL METHODS
| Compound | Analytical method | Matrix | Sample volume (µl) | Range |
| Bortezomib | UPLC/MS/MS | Human EDTA Plasma ultrafiltrate | 100 | 1-100 ng/ml |
| Capecitabine, FBAL, 5-Fu, 5-DFUR | UPLC/MS/MS | Human EDTA Plasma | 50 | Capecitabine: 100-10000 ng/ml FBAL: 200-10000 ng/ml 5-DFUR: 00-10000 ng/ml 5-Fu: 5-1000 ng/ml |
| Doxorubicin, doxorubicinol | UPLC/MS/MS | Human EDTA Plasma | 100 | 1-200 ng/ml |
| Gemcitabine, 2’,2’-Difluoro-2’-deoxyuridine (dFdU) | UPLC/MS/MS | Human EDTA Plasma | 50 | Gemcitabine:1-100ng/ml dFDU: 1000-100000 ng/ml |
| Olaparib | UPLC/MS/MS | Human EDTA Plasma | 100 | 5-5000 ng/ml |
| Paclitaxel | UPLC/MS/MS | Human EDTA Plasma | 100 | 5-1000 ng/ml |
| Paclitaxel | UPLC/MS/MS | Tissues (pig) | Biopsies | 5-1000 ng/g |
| Pomalidomide | UPLC/MS/MS | Human EDTA Plasma | 100 | 0,25-100 ng/ml |
OTHER VALIDATED BIONALYTICAL METHODS
| Compound | Analytical method | Matrix | Sample volume (µl) | Range |
| Ambroxol | UPLC/MS/MS | Human EDTA Plasma | 100 | 0.3-50 ng/ml |
| Cyclosporine A | UPLC/MS/MS | Whole blood samples (human, pigs) | 50 | 5-1000 ng/ml |
| Cyclosporine A | UPLC/MS/MS | Tissues (pig) | Biopsies | 5-1000 ng/g |
| Fentanyl | UPLC/MS/MS | Human EDTA Plasma | 100 | 20-5000 pg/ml |
| Fentanyl | UPLC/MS/MS | Dried blood sploot | 25 | 200-50000 pg/ml |
| Ibuprofen (R-(-)-ibuprofen; S-(+)-ibuprofen) |
UPLC/MS/MS | Human EDTA Plasma | 100 | 10-10000 ng/ml |
| Loperamide | UPLC/MS/MS | Human EDTA Plasma | 100 | 100-25000 pg/ml |
| Megestrol | UPLC/MS/MS | Human EDTA Plasma | 100 | 1-200 ng/ml |
| Methylphenidate (d-methylphenidate, l-methylphenidate) |
UPLC/MS/MS | Human Potassium oxalate with sodium fluoride plasma | 100 | 0.1-20 ng/ml |
| Monomethyl fumarate | UPLC/MS/MS | Human Potassium oxalate with sodium fluoride plasma | 250 | 10-2000 ng/ml |
| Monoethyl fumarate | UPLC/MS/MS | Human Potassium oxalate with sodium fluoride plasma | 250 | 10-2000 ng/ml |