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Related Experiment Videos

Stability of deslorelin injection

G C Wood1, C Dass, M R Iyer

  • 1Parenteral Medications Laboratory, University of Tennessee, College of Pharmacy, Memphis 38163, USA.

PDA Journal of Pharmaceutical Science and Technology
|November 14, 1997
PubMed
Summary
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Deslorelin injectable drug formulation shows excellent stability at 6°C, with no degradation observed over 5 years. Accelerated stability studies predict a shelf-life exceeding 20 years under refrigeration, crucial for long-term therapeutic use.

Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Drug Stability

Background:

  • Deslorelin is a nonapeptide drug used in injectable formulations.
  • Assessing the long-term stability of deslorelin is critical for its clinical application and ensuring therapeutic efficacy.

Purpose of the Study:

  • To evaluate the stability of deslorelin in an injectable formulation over 60 months.
  • To establish the shelf-life of deslorelin injection under various storage conditions.

Main Methods:

  • High-performance liquid chromatography (HPLC) was developed and validated to quantify deslorelin and benzyl alcohol.
  • Samples were stored at controlled temperatures (-10, 6, 25, 40, and 50°C) for stability assessment.
  • Liquid secondary ionization mass spectrometry (LSI-MS) was used to identify degradation products.

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Main Results:

  • Deslorelin demonstrated no degradation at 6°C over 5 years.
  • Degradation increased with temperature at 25°C, 40°C, and 50°C.
  • Predicted T90 (time for 10% degradation) at 6°C exceeded 20 years.
  • Hydrolysis yielding a hexapeptide and oxidation of the tryptophan ring were identified as degradation pathways.

Conclusions:

  • The injectable deslorelin formulation is highly stable when stored at 6°C.
  • Refrigerated storage is recommended to ensure the drug's integrity and therapeutic effectiveness.
  • Understanding degradation pathways aids in formulation optimization and quality control.