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Prashant Pandey
M.Pharm. (Pharmaceutics)
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Type condition to be maintained
1) Chemical Chemical integrity & labeled
potency
2) physical Appearance & palatability ,
uniformity
3) microbiological sterile
4) therapeutic Drug should remain potent
5) toxic Should not be toxic
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Pharmaceutical products often may exhibit physical or chemical
reaction that may end in instability.
This degradation may lead to
1)Reduced activity of preparation
2)Formation of toxic products
3)Inelegant product
Stability testing is necessary to ensure the degradation has not
exceed an acceptable level assuring
1)Safety of the patient
2)Activity of the product
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Hydrolysis
Oxidation-reduction
Racemisation
Decarboxylation
Ring cleavage
Photolysis
isomerisation
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Many pharmaceutical preparations contain ester, amide groups
Ester hydrolysis:
The hydrolysis of an ester in to mixture of acid &alcohol
essentially involves the rupture of a covalent linkage between
carbon atom &oxygen atom
Ester + H + (OR) OH - Acid + Alcohol
Drugs under go hydrolysis –procaine, atropine, asprin
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Amide hydrolysis:
Pharmaceutical compound containing amide under go hydrolysis
it gives acid &amine
Amide + h2o acid + amine
Drugs under go amide hydrolysis –niacinamide,
phenethicillin, chloramphenicol, barbiturates
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By avoiding contact with water vapour control of atmospheric
humidity during preparation & packing
Adjusting ph to an optimum level
Hydrolytic reactions generally minimized by partial (or) full
replacement of water with lower dielectric constant sol such as
glycol, glucose, mannitol
By modification of chemical structure by increasing the length
of branching the alkyl groups, hydrolysis of ester may be
decreased by owing to steric hindrance.
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Oxidation involves addition of oxygen, removal of hydrogen
Fe++ Fe+++ +1e-
RH R0 + (H) free radical
Oxidative degradation influenced by light and heat
Drugs which under go oxidative decomposition are
ergometrine, heparin, tetracyclines, amikacine , morphine,
neomycine, norepinephrine, paraldehyde, reserpine, terpenes,
tubacurarine, riboflavin, physostigmine, Vitamin D, K, C
ACCELERATED STABILITY TESTING.pdf
Type condition to be maintained
1) Chemical Chemical integrity & labeled
potency
2) physical Appearance & palatability ,
uniformity
3) microbiological sterile
4) therapeutic Drug should remain potent
5) toxic Should not be toxic
Pharmaceutical products often may exhibit physical or chemical
reaction that may end in instability.
This degradation may lead to
1)Reduced activity of preparation
2)Formation of toxic products
3)Inelegant product
Stability testing is necessary to ensure the degradation has not
exceed an acceptable level assuring
1)Safety of the patient
2)Activity of the product
Hydrolysis
Oxidation-reduction
Racemisation
Decarboxylation
Ring cleavage
Photolysis
isomerisation
Many pharmaceutical preparations contain ester, amide groups
Ester hydrolysis:
The hydrolysis of an ester in to mixture of acid &alcohol
essentially involves the rupture of a covalent linkage between
carbon atom &oxygen atom
Ester + H + (OR) OH - Acid + Alcohol
Drugs under go hydrolysis –procaine, atropine, asprin
Page 7 of 39
Amide hydrolysis:
Pharmaceutical compound containing amide under go hydrolysis
it gives acid &amine
Amide + h2o acid + amine
Drugs under go amide hydrolysis –niacinamide,
phenethicillin, chloramphenicol, barbiturates
Page 8 of 39
By avoiding contact with water vapour control of atmospheric
humidity during preparation & packing
Adjusting ph to an optimum level
Hydrolytic reactions generally minimized by partial (or) full
replacement of water with lower dielectric constant sol such as
glycol, glucose, mannitol
By modification of chemical structure by increasing the length
of branching the alkyl groups, hydrolysis of ester may be
decreased by owing to steric hindrance.
Page 9 of 39
Oxidation involves addition of oxygen, removal of hydrogen
Fe++ Fe+++ +1e-
RH R0 + (H) free radical
Oxidative degradation influenced by light and heat
Drugs which under go oxidative decomposition are
ergometrine, heparin, tetracyclines, amikacine , morphine,
neomycine, norepinephrine, paraldehyde, reserpine, terpenes,
tubacurarine, riboflavin, physostigmine, Vitamin D, K, C
A
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