- Mots-clés > Active Pharmaceutical Ingredient - API
- Mots-clés > antimalarial active pharmaceutical ingredients
- Mots-clés > API starting material
- Mots-clés > artemisinin
- Mots-clés > artemisinin - antimalarial active pharmaceutical ingredients
- Mots-clés > artemisinin - starting material
- Mots-clés > artemisinin starting material - tests and specifications
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > quality assurance
- Mots-clés > raw material
(2015; 8 pages)
The purpose of this document is to offer a global approach to defining the level of quality requirements of artemisinin when used as a starting material for the production of its API derivatives used in ACT formulations. It does not apply to cases where artemisinin is used as an API. It is intended that the recommendations for requirements outlined in this document will apply to artemisinin extracted from Artemisia annua L. regardless of variations in agricultural environment or variations in extraction and purification steps.
In addition, in order to ensure appropriate quality of the derived APIs, the manufacturer may add additional tests, such as tests for residual solvents and heavy metals, among others, and/or require tighter specifications. For artemisinin produced using synthetic chemical processes or by fermentation other requirements may be applicable.