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[Stability control of a copper histidinate solution]
V Leclercq1, M Torck, B Guislain
1Pharmacie centrale, CHRU de Lille.
Annales Pharmaceutiques Francaises
|January 1, 1996
Summary
Subcutaneous copper histidinate shows promise for Menkes disease treatment. This study confirms the stability of copper (II)-L-histidine complexes, crucial for validating production methods.
Area of Science:
- Biochemistry
- Pharmacology
- Materials Science
Context:
- Menkes disease is a rare genetic disorder affecting copper metabolism.
- Subcutaneous administration of copper compounds is being explored as a therapeutic strategy.
- Copper histidinate is a potential candidate for Menkes disease treatment.
Purpose:
- To characterize the complex formation of Copper (II) with L-Histidine in a 1:2 molar ratio.
- To assess the stability of the Copper (II)-L-Histidine complex under various conditions.
- To validate production methods for copper histidinate for potential therapeutic use.
Summary:
- The study successfully controlled the complex formation of Cu (II)-L-Histidine at a 1:2 molar ratio.
- The stability of the resulting complex was verified under specific determination and validation conditions.
- This provides foundational data for the reliable production of copper histidinate.
Impact:
- Establishes critical parameters for the quality control of copper histidinate.
- Supports the development of stable and effective copper-based therapies for Menkes disease.
- Contributes to the validation of manufacturing processes for pharmaceutical applications.