Types of Spoilage in Pharmaceutical Products
- S-3-PHARMACEUTICAL MICROBIOLOGY
- Feb 28
- 1 min read
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Spoilage in Pharmaceutical Products can be categorized into three main types:
While all types are important, microbial spoilage is the focus here due to its direct impact on product safety.
1) Chemical Spoilage in Pharmaceutical Products
Definition
Degradation of the active pharmaceutical ingredient (API) or excipients due to chemical reactions.
Examples
Oxidation: API reacting with oxygen leading to loss of potency.
Hydrolysis: Breakdown of compounds due to reaction with water.
Photolysis: Degradation caused by exposure to light.
Impact
Loss of efficacy, formation of toxic degradation products.
2) Physical Spoilage
Definition
Changes in the physical properties of the product without altering chemical composition.
Examples
Caking: Clumping of powders.
Phase Separation: In emulsions and suspensions.
Precipitation: In solutions due to temperature changes.
Impact
Affects drug delivery, dosing accuracy, and patient acceptability.
3) Microbial Spoilage
Definition
Deterioration of the product due to the growth and metabolic activities of microorganisms.
Examples
Visible Mold Growth: On tablets or creams.
Bacterial Contamination: Leading to turbidity in solutions.
Gas Production: Causing containers to bulge.
Impact
Potential infection risk, reduced efficacy, product recalls.
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