ANALYTICS

Analytical and bioanalytical development

  • 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

LIST OF VALIDATED BIOANALYTICAL METHODS

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

GALENICS

  • 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