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Hameln rds has received CEP from EDQM for API SUFENTANIL CITRATE, we will be happy to prepare you a quote.
- Development and validation/verification of analytical methods according to ICH guidelines
- Development of bioanalytical methods (Sample preparation, LC/MS/MS)
- Trace quantitative analysis in various kinds of matrix
- Validation of bioanalytical methods according to EMA guidelines
- Analysis according to EP, BP and USP
- Physical, chemical & microbiological tests
- Analytical method transfer
- Photostability / compatibility testing
- Analytical support to the GD and API facilities and the customer request as well
- Small scale isolation and partial identification of impurities
- Proteomics analysis (cooperation with university in the scope of EU project)
- LIMS available for analysis management
| Compound | Matrix | Method | Compound | Matrix | Method |
| ACEBUTOLOL | Human Plasma | LC/UV | DONEPEZIL | Human Plasma | LC/MS/MS |
| AGAPURIN | Human Plasma | LC/UV | DULOXETINE | Human Plasma | LC/MS/MS |
| ALLOPURINOL | Human Plasma | LC/MS/MS | ETHINYL ESTRADIOL +DROSPIRENONE | Human Plasma | LC/MS/MS |
| AMBROXOL | Human Plasma | GC/ECD,LC/UV | FENOFIBRATE | Human Plasma | LC/UV |
| AMLODIPINE | Human Plasma | GC/ECD,LC/UV | FEXOFENADINE | Human Plasma | LC/UV |
| AMLODIPINE +OLMESARTAN | Human Plasma | LC/MS/MS | FLUCONAZOLE | Human Plasma | LC/UV |
| ATORVASTATIN | Human Plasma | LC/MS/MS | FUROSEMIDE | Human Plasma | LC/UV |
| BETAXOLOL | Human Plasma | LC/UV | GLIMEPIRIDE | Human Plasma | LC/MS |
| BEZAFIBRATE | Human Plasma | LC/MS/MS | IBUPROFEN | Human Plasma | LC/UV |
| BISOPROLOL | Human Plasma | LC/UV | IRBESARTAN | Human Plasma | LC/MS/MS |
| CARVEDILOL | Human Plasma | LC/UV | ISOSORBIT-MONONITRATE | Human Plasma | GC/ECD |
| CIPROFLOXACIN | Human Plasma | LC/UV | KINEDRYL | Human Plasma | LC/UV |
| CITALOPRAM | Human Plasma | LC/UV | LEVODOPA | Human Plasma | LC/MS/MS |
| CLOPIDOGREL | Human Plasma | LC/MS/MS | LORATADINE | Human Plasma | GC/ECD |
| DHC | Human Plasma | LC/UV | LOSARTAN | Human Plasma | LC/UV |
| DIAZEPAM | Human Plasma | LC/UV | LOVASTATIN | Human Plasma | LC/UV |
| DICLOFENAC | Human Plasma | LC/UV | MALOTILATE | Human Plasma | GC/ECD |
| MELOXICAM | Human Plasma | LC/UV | RABEPRAZOLE | Human Plasma | LC/MS/MS |
| MEMANTINE | Human Plasma | LC/MS/MS | RAMIPRIL | Human Plasma | LC/MS |
| METFORMIN | Human Plasma | LC/MS | RIVASTIGMINE | Human Plasma | LC/MS/MS |
| METOPROLOL | Human Plasma | LC/UV | SELEGILINE | Human Plasma | GC/ECD |
| MORPHINE | Human Plasma | LC/UV | SERTRALIN | Human Plasma | GC/ECD |
| NTG | Human Plasma | GC/ECD | SILDENAFIL | Human Plasma | LC/MS/MS |
| OMEPRAZOLE | Human Plasma | LC/UV | SUFENTANIL | Human Plasma | LC/MS/MS |
| ONDANSETRON | Human Plasma | LC/UV | TAMOXIFEN | Human Plasma | LC/UV |
| PENICILLIN V | Human Plasma | LC/MS | TERBINAFIN | Human Plasma | LC/UV |
| PENTOXYFILÍN | Human Plasma | LC/UV | TETRAZEPAM | Human Plasma | LC/UV |
| PENTOXYFILÍN CHLORTALIDON | Human Plasma | LC/UV | TRAMADOL | Human Plasma | LC/FL |
| PERINDOPRIL/AT | Human Plasma | LC/MS | TRAMADOL + IBUPROFEN | Human Plasma | LC/FL |
| PETN | Human Plasma | LC/MS | TRIMETAZIDINE | Human Plasma | LC/UV |
| PHAMOTIDINE | Human Plasma | LC/UV | VENLAFAXINE | Human Plasma | LC/UV |
| PHENYTOIN | Human Plasma | LC/UV | WARFARIN | Human Plasma | LC/UV |
| PIRACETAM | Human Plasma | LC/UV | ZALEPLON | Human Plasma | LC/UV |
| PROPENTOPHYLLINE | Human Plasma | LC/UV | ZOLPIDEM | Human Plasma | LC/MS/MS |
| ZOPICLON | Human Plasma | LC/UV |
- Galenical Development of following forms:
- Vials, Ampoules
- Prefilled Syringes
- Lyophilisates
- Support by Technology Transfer to the CMOs
- Support during validation of technological process
- Active cooperation during solving of defficiency letters from competent authorities
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