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Pharmacopeia (Parameters for identification (Appearance (phase, form,…

- - - - date after which the product is deemed no longer fit for dispensing
      - Not to be confused with Shelf Life: timescale within which product guaranteed to be within specifications.
  - - - Not all drug monographs revised (no need)
- - - - Look up name
      - Find Specifications
      - Range of precise tests
    - - General methods for carrying out tests
- - - - Mistakes in production
      - Counterfeit use of drugs
      - Alduteration
        
        . drug mixed/cut with another, cheaper compound
  - - - Simple chemical tests
        
        Drug added to reagents that will cause the generation of a coloured complex product (if +ve)
      - Infrared (IR) spectrum
        
        Using an IR spectrometer, a sample is irradiated with IR radiation to give characteristic spectrum
      - Chromatographic
        
        Standard solution run alongside standards (pure drug and known potential contaminants)
        
        Thin Layer Chromatography
        
        Standard run at same time as unknowns.
        
        n=2, minimum
        
        An Infra Red Spectrum
        
        useful for identification
        
        compare unknown to reference database
        
        all major absorptions must correlate
        
        complicated unique to a compound
    - - How much of the analyse per unit mass or volume of test substance
        
        Correct amount of drug present?
        
        typically, 95-99%
    - - Some drugs prone to contamination with eg, precursors, metal microparticulates or ions