1

Stability and storage

Rx25 Rangsit university
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45 2 oC
(Accelerated storage 4
75 5 %RH
condition)

o
0, 3, 6, 9, 12, 18
30 2 C
(Real time storage 24
75 5 %RH
condition)

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Shelf-life
10% labeled
amount 90%

Expiration date

60
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5
2-3
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(Beyond-use date)

1

25% 6

14

30



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!!!

1 Chemical degradation

Physical degradation
2
Microbiological degradation
3
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Chemical degradation

Hydrolysis
Oxidation O2
Photolysis
Hydration
Dehydration
Decarboxylation CO2
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Physical degradation

Polymorphism polymorph

Adsorption interaction
Physical instability in heterogeneous system
suspensions emulsions
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Microbiological degradation

Hydrolysis, oxidation
reduction
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Uncoated (erosion)
tablets (cracking) (swelling)

Coated (cracking) (discoloration)
tablets (sticking/picking)
Powders
Suppositories
capsules
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Picking punch (
)
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Sticking punch
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Capping
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Cracking
( Capping)
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Laminating
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Chipping
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Mottling ()

Drug migration
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Solutions or syrup
Emulsions
Suspensions
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Creams
Ointments
Gels
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Freezer -20 C -10 C

Cold 8 C
Refrigerator 2-8 C
Cool 8-15 C
Room temperature
Controlled room 28-32 C
temperature ()
Warm 30-40 C
Excessive heat 40 C