Artesunate Powder

what is Artesunate powder?

KINTAI As a manufacturer of Artemisia Annua Extract Artesunate powder, we produce artesunate, a derivative of artemisinin that improves the water solubility and therapeutic effect of artemisinin. Artemisinin itself is a sesquiterpene lactone extracted from the medicinal plant Artemisia annua and has a strong anti-malarial effect. Artesunate is a natural pharmaceutical ingredient, also known as artemisinin dioxide or artemisinin peroxide. Its main components are artemisinin and succinic acid diester.

Since artemisinin itself has low bioavailability and short duration of efficacy, in order to improve its efficacy and stability, we combined it with a succinic acid diester to form artesunate. Artesunate has become the international gold standard in the treatment of severe malaria and is widely used in various fields. It is an important plant extract.

As a starting material, the main quality problem of artemisinin is the possible presence of impurities, which may come from plant extraction, purification processes or degradation products. According to laboratory studies, artemisinin and artemisinin diastereomers are commonly found in the artemisinin samples we purchased. These impurities may affect the purity of subsequent derivative APIs. Current detection methods may not fully detect these impurities, so we use more sensitive mass spectrometry detectors for detection. The results showed that except for trace amounts of other impurities, the isolated artemisinin was very stable and no degradation products were detected.

Testing methods and quality standards for Kintai's starting material artemisinin

The standards for the starting material artemisinin include appearance, content, identification and inspection of related substances. Identification is mainly carried out through infrared spectrophotometry, and attention should be paid to the detection of impurities. For content determination, we use high-performance liquid chromatography to ensure that the relative retention time of artemisinin and impurities and the area of the relevant peaks meet the specified standards. If you need a test report, please contact us to obtain it.

Kintai focuses on the raw materials of artesunate powder: the criticality and quality control of starting materials

1. Ensure the quality of starting materials.

We conducted in-depth research on the selection, sources and production processes of starting materials, and referred to relevant information and standards, including the guidance of the China Food and Drug Administration and the exchange of practical experience in the industry, to ensure the quality of starting materials. The quality meets the requirements.

2. Strict supervision and review

Whether the starting materials are extracted from Chinese medicinal materials or obtained through fermentation processes, they are subject to strict review and supervision. We realize that the management of starting materials needs to follow good production practices from the initial steps of production and be included in the GMP management system.

3. Guarantee the quality of the final product:

For the production of important drugs such as artemisinin, we strictly follow the coordinated pharmaceutical manufacturing quality management specifications to ensure that the starting materials meet specific chemical properties and structural requirements to ensure the quality and safety of the final product Effect.

4. Continuous pursuit of excellence:

We continuously strive to ensure that the quality and purity of starting materials meet international standards and strictly control any possible impurities in artesunate powder. At the same time, we also continue to pay attention to changes in industry standards and regulatory requirements to ensure that our products always comply with the latest regulations and standards and provide high-quality pharmaceutical products to patients around the world.