3. Health products
Industrial Products (Testing)
• health products include medicines, toiletries and cosmetics
• required to meet exacting standards
• quality, safety and efficacy
• because of their direct interaction with the body
• Therapeutic Goods Administration
• oversees the development of new products and the manufacturing of
existing ones
• perform random inspections of facilities
• testing and production records must be kept for seven years
CLASS EXERCISE 3.1
List techniques suitable for analysis of organic compounds
• infrared
• UV/VIS
• fluorimetry
• GC
• HPLC
• NMR
• MS
• polarimetry
Reasons for testing
• identification of raw materials
• is it what it’s supposed to be?
• assay of active ingredients
• is there the right amount in the product?
• checking for levels of impurities
• are known impurities below specified limits?
• determining appropriate storage conditions
• time, temperature etc
• physical properties
• does the product behave as it’s supposed to?
Identification
• qualitative analysis
• white powders, colourless liquids
Exercise 3.2
(a) How would you check the identity of a pure organic compound?
• IR
(b) How would you check the identity of an organic compound, supplied as a
solution in water?
• HPLC, MS
(c) How would you check the identity of a substance, whose active form is one
particular optical isomer?
• polarimetry
Assay
• determine the concentration of the active substance
• performed on the raw material or on the final product
• for complex products with many components (e.g. shampoos) it can be
quite difficult to analyse each component
Question (not in notes)
The levels of ingredients such as eucalyptus oil can’t be analysed in the final
product. Why not?
• they are mixtures
• only their components can be analysed
CLASS EXERCISE 3.3
(a) Why would you assay a sample of raw material, after it is has been
confirmed that it is the right substance?
• check that it is 100% (or as specified)
(b) Why would you assay the final product (tablet/powder/lotion/cream etc)?
• legal requirement – must match labelling
• health effects of under/over
(c) How would you analyse the concentration of an organic compound in a
health product?
• HPLC or GC most useful because of the complex mixtures involved
• UV/VIS in simpler cases (e.g. aspirin tablets)
Impurity checks
• impossible to eliminate impurities in any manufacturing process
• ensure that they are at levels that will not cause problems
• quantitative analysis to determine the concentration
• semi-quantitative (limit) tests that give a positive/negative result
• depending on whether the impurity is above a certain concentration
• is it visible on a thin layer chromatography plate?
• is there any soluble matter in the product?
• does the addition of a specific colour-forming reagent show an absorbance
above a specified value?
• is there a peak in the GLC at X minutes with a peak area greater than Y?
Physical tests
• measure the performance, rather than the chemical concentrations
Exercise 3.5
Toothpaste
• viscosity, smell, flavour, colour, pH
Perfume
• smell
Moisturising cream
• viscosity, smell
Shampoo
• viscosity, smell, pH
• read the information about these tests for yourself
Sampling (Exercise 3.6)
(a) How would you obtain a laboratory sample of hand cream from a 1000 L
mixing vessel which is used to fill jars?
• should already be uniform
• a sample from the top (if accessible) or the outlet
• amount depends on how much will be needed
• (b) How would you obtain a sample of paracetamol for identification and
assay from a thousand 20 kg bags that have just arrived by truck on ten
pallets?
• each individual batch (consult supplier’s info) needs to be tested
• take a scoop from 2 bags from each batch
• keep samples from different batches separate