Lurasidone Impurities

General Information

Lurasidone Impurities and Lurasidone 

For evaluating the purity and safety of Lurasidone, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Lurasidone impurity standards. These impurity standards include crucial compounds such as Endo-Epoxide impurity of Lurasidone, Lurasidone Endo Hydroxy, Lurasidone Endo-RS+SR Isomer (Cis-Endo), Lurasidone isomer-1, Lurasidone Olefin Impurity-1, and more. Additionally, Daicel Pharma provides worldwide delivery options for Lurasidone impurity standards.

Lurasidone [CAS: 367514-87-2] is an atypical antipsychotic medication for treating schizophrenia and bipolar depression. It acts as an adrenergic, dopaminergic, and serotonergic antagonist, making it a second-generation antipsychotic agent. Lurasidone, in its hydrochloride salt form, is used for therapeutic purposes.

Lurasidone: Use and Commercial Availability  

Lurasidone, marketed under the brand name Latuda, is a medication belonging to the benzisothiazole class. It is an atypical antipsychotic used for treating schizophrenia and bipolar depression. Initially approved by the FDA for treating schizophrenia in adults, it later obtained FDA approval for bipolar depression in June 2013. It was a significant development as it became the first drug approved for monotherapy and adjunctive treatment with lithium or valproate. Subsequently, in January 2017, Lurasidone received FDA approval for schizophrenia in adolescents. In March 2018, its usage included pediatric patients (10 to 17 years of age) for treating major depressive episodes associated with bipolar depression.

Lurasidone Structure and Mechanism of Action

The chemical name of Lurasidone is (3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione. Its chemical formula is C₂₈H₃₆N₄O₂S, and its molecular weight is approximately 492.7 g/mol.

The mechanism of action of Lurasidone is unknown.

Lurasidone Impurities and Synthesis

The analysis and control of impurities in Lurasidone¹, an antipsychotic medication, is essential for ensuring its safety and efficacy. Impurities in Lurasidone formulations may include related substances and degradation products. Analytical techniques such as high-performance liquid chromatography (HPLC) and liquid chromatography (LC) help identify and quantify impurities. Stringent control measures and specifications limit the impurity levels in Lurasidone, adhering to regulatory requirements.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Lurasidone impurity standards, which include Endo-Epoxide impurity of Lurasidone, Lurasidone Endo Hydroxy, Lurasidone Endo-RS+SR Isomer (Cis-Endo), Lurasidone isomer-1, Lurasidone Olefin Impurity-1, and more. Our Lurasidone impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Lurasidone impurity standards and degradation products. Each delivery has a comprehensive characterization report.