- Palabras clave > Active Pharmaceutical Ingredient - API
- Palabras clave > antimalarial active pharmaceutical ingredients
- Palabras clave > API starting material
- Palabras clave > artemisinin
- Palabras clave > artemisinin - antimalarial active pharmaceutical ingredients
- Palabras clave > artemisinin - starting material
- Palabras clave > artemisinin starting material - tests and specifications
- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > quality assurance
- Palabras clave > 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.