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 degrees for 30 days; 70 degrees for 3-7 more days

Humidity (%)

100

Countries Studied In

N/A (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
  • The substance, originally in the form of colorless crystals or a white or almost white powder, changes after procedures A and B into a viscous, amber-colored solution.
  • After procedures A and B there was a 35% gain in moisture
  • No degradation was detected on thin-layer chromatography
  • Author's conclusions: No decomposition is detected by thin-layer chromatography, but the appearance of the substance changes after procedures A and B.

Reference
Accelerated stability studies of widely used pharmaceutical substances under simulated tropical conditions. World Health Organization http://apps.who.int/medicinedocs/en/d/Jh1808e/

MeSH Entry Terms
  • Damilen
  • Domical
  • APS Brand of Amitriptyline Hydrochloride
  • Rhône-Poulenc Rorer Brand of Amitriptyline Hydrochloride
  • Rhône Poulenc Rorer Brand of Amitriptyline Hydrochloride
  • Tryptine
  • Amrad Brand of Amitriptyline Hydrochloride
  • Tryptizol
  • Cahill May Roberts Brand of Amitriptyline Embonate
  • Merck Sharp and Dohme Brand of Amitriptyline Hydrochloride
  • DDSA Brand of Amitriptyline Hydrochloride
  • Tryptanol
  • Merck Sharp and Dohme Brand of Amitriptyline Embonate
  • Zeneca Brand of Amitriptyline Hydrochloride
  • Elavil
  • Cahill May Roberts Brand of Amitriptyline Hydrochloride
  • Amineurin
  • Neuro Hexal Brand of Amitriptyline Hydrochloride
  • Hexal Brand of Amitriptyline Hydrochloride
  • Amitrip
  • Protea Brand of Amitriptyline Hydrochloride
  • Amitriptylin beta
  • beta, Amitriptylin
  • Betapharm Brand of Amitriptyline Hydrochloride
  • Amitriptylin Desitin
  • Desitin, Amitriptylin
  • Desitin Brand of Amitriptyline Hydrochloride
  • Amitriptylin RPh
  • RPh, Amitriptylin
  • Rodleben Brand of Amitriptyline Hydrochloride
  • Amitriptylin-neuraxpharm
  • Amitriptylin neuraxpharm
  • Amitriptylinneuraxpharm
  • neuraxpharm Brand of Amitriptyline Hydrochloride
  • Amitriptyline Hydrochloride
  • Laroxyl
  • Roche Brand of Amitriptyline Hydrochloride
  • Endep
  • Alphapharm Brand of Amitriptyline Hydrochloride
  • Lentizol
  • Parke Davis Brand of Amitriptyline Hydrochloride
  • Novoprotect
  • Merck Brand of Amitriptyline Hydrochloride
  • Saroten
  • Bayer Brand of Amitriptyline Hydrochloride
  • Sarotex
  • Lundbeck Brand of Amitriptyline Hydrochloride
  • Syneudon
  • Krewel Brand of Amitriptyline Hydrochloride
  • Triptafen
  • Goldshield Brand of Amitriptyline Hydrochloride
  • Amitrol
  • Douglas Brand of Amitriptyline Hydrochloride
  • Anapsique
  • Psicofarma Brand of Amitriptyline Hydrochloride
  • Apo-Amitriptyline
  • Apo Amitriptyline
  • ApoAmitriptyline
  • Apotex Brand of Amitriptyline Hydrochloride
Written by: Alex Evans, PharmD
Reviewed by:
Last updated: June 10, 2013