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General methods

• 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