Unit I

Sources of impurities in medicinal

agents
By
Mrs. Shinde Pooja N.
SPMS College of pharmacy, Akluj.
 Impurity
Impurity is the undesirable foreign material or unwanted material
present in pharmaceutical substances which may or may not be toxic.

Sources of impurities

1. Raw material -
Raw material should be of pure quality.
If impurties are present in raw material then these may carried in final
product
Example – Copper sulphate is prepared by addition of sulphuric acid in
copper. If copper contains impurity beyond the limit the final product also
contains impurity beyond the limit.
Cu + H2SO4 CuSO4 + H2
 2. Reagent used in manufacturing process

Reagents used in manufacturing process should be completely

remove impurity by washing with water or any other appropriate
solvent
.
Example - Precipitate of calcium carbonate prepared by using
calcium chloride and sodium carbonate. When these react with each
other it form precipitate of calcium carbonate. If this precipitate is
not properly washed with water it may contains carbonate as an
impurity.

CaCl2 + NaCO3 CaCO3 + 2NaCl2

 3. Internediate product formed in
manufacturing process
Sometimes some intermediates are formed during manufacturing
process which will converted into final product.
Example – Potassium iodide is prepared by reaction of potassium
hydroxide and iodine. Potassium iodate is intermediate product
which is converted into potassium iodide when it heated and
prepared with charcoal.
If potassium iodate is not properly heated and evaporated with
charcoal it will not get completely converted into potassium iodate.
Potassium Hydroxide + Iodine Potassium iodate

Potassium iodide
 4. Default in manufacturing process

To prepare any substance or any chemical compound it require

proper mixing, suitable temperature and PH.

If mixing is incomplete at unsuitable temperature and PH then

it contains impurity in final product.
Example - Emulsification
 5. Solvents
Water is one of cheapest solvent which is commonly used.
There are many types of water
1. Tap water
2. Soft water
3. Demineralised water
4. Distilled water
1. Tap water – It contains calcium, magnesium, sodium chloride as
an impurity therefore not used in manufacturing.
It used for washing apparatus.
2. Soft water - Prepared by passing tap water through sodium
zeolite candle where divalent ions are replaced with sodium. It
means it contains more amount of sodium impurities, so it not
used for manufacturing.
3.Demineralised water –
Minerals are absent.
It is better solvent but it contains organic impurities.

4. Distilled water –
Prepared by distillation.
It is free from organic as well as inorganic type of impurities.
So it is ideal solvent used in manufacturing process.
 6. Action of solvent and reagent on vessel
Most commonly used metal are stainless steel, aluminium,
copper, iron and glass are also used for construction of vessel.
Some reagents used in manufacturing process react with metal
and traces of metal incorporate in to solution and finally
contaminate the product.
Similarly glass vessel may traces alkali to the solvent.
Example – Strong acid leaches out alkali from borosilicate glass.
Copper and zinc react with slightly acidic substances.
Stainless steel and hard glass commonly used for manufacturing
of vessels. It contains less amount of impurities.
 7. Defective storage of final product
Some pharmaceutical chemicals undergoing chemical
decomposition if they are not stored properly.

Example – 1. Ferrous sulphate

When exposed to air it becomes brownish.

2. Some drugs get decomposed due to light so it should be stored

in light resistant container. Example amber coloured glass.
 8. Adultration

Some pharmaceutical chemicals may adulterated with cheaper

substances.
It have some physical properties.

Example – Potassium bromide may adulterated with sodium

bromide. Both have same physical properties.
Sodium bromide is cheaper substance