Brand Name

Not specified

Dosage Form

Not specified

Strength

Not specified

Manufacturer

Not specified

Conditions Studied

  • Medication was protected from light
  • Procedure A: 30 days at 50 degrees C and 100% relative humidity
  • Procedure B: 30 days at 50 degrees C and 100% relative humidity followed by 5 days at 70 degrees C and 100% relative humidity

Temperature (degrees Celsius)

50, 70

Humidity (%)

100

Countries Studied In

Not applicable (laboratory study)

Definition of Stability

  • A standard for a degraded sample was created that contained 10% degradation products and 90% of the label.
  • This standard was used to compare to the tested product during analytical testing.

Conclusions and Length of Stability
  • Gain of moisture:
    • Before exposure to heat and humidity:6%
    • Procedure A: 27%
    • Procedure B: 30%
  • Author's conclusions: Amphotericin B is subject to decomposition under accelerated degradation conditions.


Reference
http://apps.who.int/medicinedocs/en/d/Jh1808e/

MeSH Entry Terms
  • Fungizone
  • Amphotericin B Cholesterol Dispersion
  • Amphotericin B Colloidal Dispersion
  • Amphocil
  • Amphotericin
MeSH Reference: http://www.ncbi.nlm.nih.gov/mesh/68000666
Written by: Alex Evans, PharmD
Reviewed by:
Last updated: June 10, 2013