Istradefylline
General Information
Istradefylline Impurities and Istradefylline
Daicel Pharma offers superior-quality Istradefylline impurities, such as Istradefylline Impurity. These impurities are essential for evaluating Istradefylline quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Istradefylline impurities and ensures their worldwide delivery.
Istradefylline [CAS: 155270-99-8] blocks adenosine A2A receptor activity, helping adult patients with Parkinson’s disease. It is a fused pyrimidine derivative with antiparkinsonian effects. It was first developed by Kyowa Hakko Kirin, Japan. It is considered as an alternative medicine to dopaminergic drugs.
Istradefylline: Use and Commercial Availability
Istradefylline is used with levodopa/carbidopa in patients with Parkinson’s disease who have motor fluctuations, such as dyskinesia and hallucinations. It helps improve the quality of life of these patients. The US FDA approved it in 2019. Istradefylline is available as an oral formulation under Nourianz and Nouryant.
Istradefylline Structure and Mechanism of Action
The chemical name of Istradefylline is 8-[(1E)-2-(3,4-Dimethoxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-1H-purine-2,6-dione. The chemical formula for Istradefylline is C20H24N4O4, and its molecular weight is approximately 384.43 g/mol.
Istradefylline inhibits the activity of adenosine A2A receptors found on some brain cells, controlling movement. It reduces overactive striatopallidal output and GABAergic activity.
Istradefylline Impurities and Synthesis
While synthesizing Istradefylline 1, impurities may form that will affect drug safety and efficacy. They form during the synthetic process, storage, or purification of Istradefylline. Manufacturers can control and monitor Istradefylline impurities to improve the drug’s safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Istradefylline impurities, which includes Istradefylline Impurity. The CoA provided to clients is from a cGMP-compliant analytical facility with the complete characterization data2 such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Istradefylline impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Istradefylline. Daicel Pharma provides a complete characterization report accompanying the delivery.
References
- Suzuki, Fumio; Shimada, Junichi; Koike, Nobuaki; Nakamura, Joji; Shiozaki, Shizuo; Ichikawa, Shunji; Nonaka, Hiromi, Therapeutic agent for Parkinson's disease, US5484920A, Jan 16,1996, Kyowa Hakko Kogyo Co., Ltd., Japan (https://patents.google.com/patent/US5484920A/en)
- Xu, Haojie; Wang, Yiyun; Wang, Hongyi; Zheng, Zhonghui; Meng, Zihui; Xue, Min; Xu, Zhibin, Separation and identification of an impurity from the Istradefylline intermediate, RSC Advances, Volume: 10, Issue: 25, Pages: 14493-14499, 2020 DOI: (10.1039/c9ra09074f)
Frequently Asked Questions
2.How do you identify the Istradefylline impurities?
HPLC and preparative HPLC help to identify the Istradefylline impurities.
3.How does the Istradefylline drug degrade?
Istradefylline degrades under light to an isomer, Z-Istradefylline.
4.Why is it necessary to control the Istradefylline impurities in the drug?
Istradefylline impurities can affect drug safety, quality, and efficacy. Because they may cause adverse effects, it is extremely necessary to control the impurities in the drug.
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