Stability Study for Drugs, Personal Care Products and Cosmetics
What is Shelf life of Drugs, Personal Care/Cosmetic Products?
Shelf-life is the extent to which a product retains, within specified limits, and throughout
its period of storage and use the same physical, chemical and antimicrobial
specifications and characteristics that it possessed at the time of its manufacture and
packaging. The product must retain 90% of the labeled claim at the end of shelf-life.
As per USP there are five types of stability studies:
- Chemical: Each active ingredient should retain its chemical integrity and
labeled potency within the specified limits
- Physical: The original physical properties, including appearance, palatability,
uniformity, dissolution, and suspendability, are retained through out the
completion of the study
- Microbiological: The sterility or resistance to microbial growth is retained
according to the specified requirements. Antimicrobial agents that are present
retain effectiveness within the specified limits and conditions
- Therapeutic: The therapeutic effect remains unchanged
- Toxicological: No significant increase in toxicity occurs
Personal Care and Cosmetics testing usually covers chemical, physical and
microbiological parameters. Therapeutic and toxicological are included in
nutraceuticals, drugs and other health care products.
Parameter For Physical types studies:
- Color, Odor, Shape
- Dimensions
- Absorbance
- Dimensions
- Leakage
- Container integrity
Parameters for Chemical Analysis:
- Identification of ingredients
- Uniformity of weight, mass, volume, etc.
- Disintegration time base in formulation
- Dissolution
- Uniformity of content
- Related substance
- pH
- Presence of phytochemicals
- Presence of Alkaloids
- Refractive index
- Melting point
- Boiling point
- Organic volatile impurities
- Acid value
- Peroxide value
- Fatty acid and Esters
- Particle size
- Residual solvents
Parameters for Microbial Analysis:
- Pyrogens/ Bacteria endotoxins
- Microbial Limit Test
- Antimicrobial Effectiveness Test
- Validation Test
- Pathogen Screening
Factors affecting Stability
- Environmental factors
- Temperature
- Light
- Air
- Oxygen
- Moisture
- Carbon Dioxide
- pH of the vehicle
- Microbial contamination
- Trace metal Contamination
- Leaching from containers
When do we need stability testing and how they are conducted?
- Studies are conducted at Long Term, Intermediate, Accelerated or Tropical
conditions
Study |
Storage Condition |
Long-term |
25°C ± 2°C
60% RH ± 5% RH |
Intermediate |
30°C ± 2°C
65% RH ± 5% RH |
Accelerated |
40°C ± 2°C
75% RH ± 5% RH |
Tropical |
45 0C +20C
75% RH + 5% RH |
- Controlled room temperature conditions
- Product samples are analyzed at various intervals by validated analytical methods
General Recommendations to Follow for a Shelf Life Study: