Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria
(11 pages)
Índice de contenido
Ver el documentoSection 1. Details of the product
Ver el documentoSection 2. Regulatory situation in other countries
Cerrar esta carpetaSection 3. Active pharmaceutical ingredient (s) (API)
Ver el documentoSection 3.1 Properties of the active pharmaceutical ingredient(s)
Ver el documentoSection 3.2 Sites of manufacture
Ver el documentoSection 3.3 Route(s) of synthesis
Ver el documentoSection 3.4 Specifications
Ver el documentoSection 3.5 Stability testing
Abrir esta carpeta y ver su contenidoSection 4. Finished product
Abrir esta carpeta y ver su contenidoSection 5. Efficacy and safety
 

Section 3.1 Properties of the active pharmaceutical ingredient(s)

Provide at least the following information:

Chemical structure;

Solubility in water, other solvents such as ether, ethanol, acetone, and buffers of different pH;

Isomeric nature including stereochemical configuration;

Partition coefficient and the existence of polymorphs;

Copies of infrared, nuclear magnetic resonance (proton and C-13), ultraviolet and mass spectra;

Information on the chemical and physicochemical stability if relevant (e.g. formation of a hydrate, change of polymorphic form.

 

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Última actualización: le 3 mayo 2013