Különleges esetek megoldása

Intro

Methods in pharmaceutical analysis at WESSLING

Különleges esetek megoldása

[Translate to Magyar:]

  • Laser diffractometry, EP 2.9.31: determination of particle size
  • IR-microscopy (transmission / reflection / ATR): testing for drug authenticity / drug counterfeits, analysis of film thickness
  • Characterisation of nanomaterials in ready-to-use medicinal products
  • Spectroscopy / spectrometry: IR spectroscopy, UV-VIs spectroscopy, mass spectrometry, mass spectrometry with inductively coupled plasma (ICP-MS/OES)
  • Thin layer chromatography: identity testing, semiquantitative purity tests, quantitative purity tests, content determinations
  • Gas chromatography (GC, GC-MS): content determination / determination of RLM, identity checks, detectors: DAD, MS, TCD, feed systems: head space and split / splitless
  • Liquid chromatography (HPLC, HPLC-MS): content determination, testing for related substances, identity checks, detectors: fluorescence, DAD, UV/Vis, MS, RI
  • Sterility tests using two isolators
  • Endotoxin determinations, method A and C
  • Test for absence of THC
  • Paper chromatography
  • Determination of total organic carbon (TOC)
  • Clarity and opalescence of liquids
  • Colouring of liquids
  • Conductivity
  • pH value: potentiometric method, indicator method
  • Relative density
  • Drying loss
  • Potentiometric titration
  • Optical rotation
  • Viscosity (rotational viscometry)
  • Brookfield viscosity
  • Refractive index
  • Melting temperature
  • Boiling temperature
  • Distillation area

Identity testing of pharmaceuticals   

  • Ions and functional groups
  • Fatty oils by thin-layer chromatography
  • Phenothiazines by thin layer chromatography

Limit tests for pharmaceuticals

  • Ammonium
  • Arsenic
  • Calcium
  • Chloride
  • Magnesium
  • Heavy metals
  • Iron
  • Phosphate
  • Potassium
  • Sulfate
  • Ash/sulphated ash
  • Free formaldehyde
  • Alkaline reacting substances in fatty oils
  • Determination of metal residues
  • Testing of fatty oils for foreign oils by thin layer chromatography
  • Fatty acid composition
  • Sterols in fatty oils
  • Determination of solvent residues

Determination of the content of pharmaceuticals

  • Acid value
  • Ester value
  • Hydroxyl number
  • Iodine number
  • Peroxide number
  • Saponification number
  • unsaponifiable parts
  • Complexometric titration
  • Karl Fischer method
  • Phenol in sera and vaccines
  • Protein in polysaccharide vaccines
  • Nucleic acids in polysaccharide vaccines
  • Phosphorus in polysaccharide vaccines
  • Protein content

Methods of pharmacognosy

  • Ash insoluble in hydrochloric acid
  • Foreign components
  • Stomata Index
  • Source number
  • Pesticides
  • Determination of tannin content in herbal drugs
  • Bitter value
  • Dry residue and drying loss of extracts
  • Aflatoxins B1 in herbal drugs
  • Analysis for aistolochic acids in herbal drugs
  • Ochratoxin in herbal drugs
  • Microscopic examination of herbal drugs

Methods of pharmaceutical technology

  • Decay time of tablets and capsules
  • Decay time of suppositories and vaginal suppositories
  • Drug release from solid dosage forms by dissolution tester (on-/offline)[Paddle and Basket]
  • Compilation of release profiles (PMP/EWP/QWP/1401/98), compilation of bioequivalence studies, biowaver
  • Friability (abrasion)
  • Tablet hardness
  • Uniformity of content and mass of single-dose dosage forms
  • Visible particles
  • Particle size distribution
  • Particle contamination - invisible particles
  • Determination of the extractable volume of parenteralia
  • Ethanol content
  • Methanol and 2-propanol
  • Microscopy