ANALYTICS

Analytical and bioanalytical development

auftragsentwicklung

  • 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

Click here for 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
    • Tablets, Capsules
  • Support by Technology Transfer to the CMOs
  • Support during validation of technological process
  • Active cooperation during solving of defficiency letters from competent authorities

Gallery

Blistering-machine

Lyophilisator

Headspace GC

Cytotox Lab

Dissolution Test

Filling machine vials-ampoules

HPLC

hplc-

On-chip electrophoresis

UV Spectrophotometer

Hazard Box

More services

Analytical and Galenical Development of Pharmaceuticals

Read more

QC and Laboratory Services (Stabilities, Batch Release, Biologics)

Read more

Development and GMP production of APIs

Read more

Preclinical studies

Read more