General Information

Sumatriptan Impurities and Sumatriptan 

Daicel Pharma synthesizes high-quality Sumatriptan impurities like Sumatriptan EP Impurity E, Sumatriptan Impurity 2, Sumatriptan Impurity BP Imp-1/Sumatriptan pyrroloindolium analog, Sumatriptan Impurity-A, Sumatriptan impurity-F, Sumatriptan N-oxide, and Sumatriptan Succinate Impurity, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Sumatriptan. Moreover, Daicel Pharma offers custom synthesis of Sumatriptan impurities and delivers them globally.

Sumatriptan [CAS: 103628-46-2] is an FDA-approved medicine treating migraine attacks. It treats cluster headache episodes through subcutaneous administration. It is a sulfonamide triptan that causes vasoconstriction of cranial and basilar arteries.

Sumatriptan

Sumatriptan is effective and well-tolerated medicine for migraines, whether administered intranasally, subcutaneously, or orally. Its use helps to relieve photophobia, nausea, headache, and functional disability. Sumatriptan is available under brand names such as Alsuma, Imitrex, Onzetra Xsail, Sumavel Dosepro, Tosymra, Zecuity, and Zembrace Symtouch.

Sumatriptan Structure and Mechanism of Action

The chemical name of Sumatriptan is 3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide. Its chemical formula is C₁₄H₂₁N₃O₂S, and its molecular weight is approximately 295.40 g/mol.

Sumatriptan is a vascular-5HT1 receptor subtype agonist that causes vasoconstriction. It acts on human basilar arteries and helps in relieving migraine headaches.

Sumatriptan Impurities and Synthesis

Sumatriptan forms impurities during its synthetic¹ process. These impurities are influenced by reaction conditions, starting materials, and purification techniques. Rigorous quality control measures monitor and remove impurities during synthesis to ensure the safety and efficacy of the final product.

Daicel provides a Certificate of Analysis (CoA) for Sumatriptan impurity standards, including Sumatriptan EP Impurity E, Sumatriptan Impurity 2, Sumatriptan Impurity BP Imp-1/Sumatriptan pyrroloindolium analog, Sumatriptan Impurity-A, Sumatriptan impurity-F, Sumatriptan N-oxide, and Sumatriptan Succinate Impurity. The CoA is issued from a cGMP-compliant analytical facility and contains complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity^2,3. Additional characterization data, such as 13C-DEPT and CHN, can be provided upon request. Daicel can also prepare any unknown Sumatriptan impurity or degradation product and offer labeled compounds to quantify the efficacy of Sumatriptan. Daicel offers Sumatriptan D6 Format Salt, a deuterium-labeled Sumatriptan compound used in bio-analytical research such as BA/BE studies. We give a complete characterization report on delivery.