Brand Name

Not specified

Dosage Form

Capsules

Strength

Not specified

Manufacturer

Not specified

Conditions Studied


  • Drug batches from stocks in central distribution facilities were sampled and retained
  • In outlying clinics, samples were taken of:
    • the oldest batch of each drug: intended to reveal degradation if the drug was unstable
    • batches of drug with the same lot number as those in the central distribution facility: intended to reveal changes in stability over time when compared with samples from the central facility

Temperature (degrees Celsius)

Not specified

Humidity (%)

Not specified

Countries Studied In

Harare and Bulawayo, Zimbabwe

Definition of Stability

Meet British Pharmacopeia (BP) specifications (92.5-110%)

Conclusions and Length of Stability
  • Manufacturer's stated shelf life: 2-3 years
  • All (6/6) central facility samples met BP specifications
  • All (25/25) outlying clinic samples met BP specifications at mean age 6.4 months
  • No loss of potency was found in 5 central facility/outlying clinic pairs (samples with matched lot numbers) at mean duration of 7.7 months
  • 23/25 outlying clinic samples had expended more than half of their shelf life
  • Four expired samples were within BP specifications at mean age 28 months
  • Author's conclusions: amoxicillin is stable under the conditions studied

Reference

Nazerali H, Muchemwa T, Hogerzeil HV. Stability of essential drugs in tropical climates: Zimbabwe. World Health Organization Action Programme on Essential Drugs. Accessed August 3, 2010 at: http://apps.who.int/medicinedocs/pdf/s2206e/s2206e.pdf.

MesH Entry Terms
  • Amoxycillin
  • Amoxicilline
  • Hydroxyampicillin
  • Amoxicillin, (R*)-isomer
  • Amoxil
  • BRL-2333
  • BRL 2333
  • BRL2333
  • Clamoxyl
  • Penamox
  • Clamoxyl G.A.
  • G.A., Clamoxyl
  • Pfizer Brand of Amoxicillin Sodium Salt
  • SmithKline Beecham Brand of Amoxicillin Sodium Salt
  • Clamoxyl parenteral
  • parenteral, Clamoxyl
  • Amoxicillin monosodium salt
  • Trimox
  • Wymox
  • Actimoxi
  • Clariana Brand of Amoxicillin
  • Amoxicillin Clariana Brand
  • Amoxicillin monopotassium salt
  • Amoxicillin trihydrate
  • trihydrate, Amoxicillin
  • Polymox
MesH Reference: http://www.ncbi.nlm.nih.gov/mesh/68000658

Written by: Alex Evans, PharmD
Reviewed by: