Lurasidone

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Endo Reduced Isomer of Lurasidone HCl

  • CAT NUMBER DCTI-C-3511
  • CAS NUMBER 17812-27-0
  • MOLECULAR FORMULA C9H10O3
  • MOLECULAR WEIGHT 166.18

Endo-Epoxide impurity of Lurasidone

  • CAT NUMBER DCTI-C-2664
  • CAS NUMBER NA
  • MOLECULAR FORMULA C28H34N4O3S
  • MOLECULAR WEIGHT 506.67

Epoxy Impurity of Lurasidone HCl

  • CAT NUMBER DCTI-C-3510
  • CAS NUMBER NA
  • MOLECULAR FORMULA C9H9NO3
  • MOLECULAR WEIGHT 179.18

Lurasidone Endo Hydroxy

  • CAT NUMBER DCTI-C-2721
  • CAS NUMBER NA
  • MOLECULAR FORMULA C28H34N4O3S
  • MOLECULAR WEIGHT 508.68

Lurasidone Endo-RS+SR Isomer (Cis-Endo)

  • CAT Number DCTI-C-1708
  • CAS Number NA
  • Molecular Formula C28H36N4O2S
  • Molecular Weight 492.68
Lurasidone-DCTI-C-1210-Daicel
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LURASIDONE HYDROCHLORIDE IMPURITY F

  • CAT Number DCTI-C-1210
  • CAS Number 1373868-14-4
  • Molecular Formula C28H34N4O3S
  • Molecular Weight 506.67

LURASIDONE HYDROCHLORIDE IMPURITY J

  • CAT NUMBER DCTI-C-1212
  • CAS NUMBER NA
  • MOLECULAR FORMULA C26H34N2O4
  • MOLECULAR WEIGHT 438.57
Lurasidone-DCTI-C-1211-Daicel
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LURASIDONE HYDROCHLORIDE IMPURITY L

  • CAT Number DCTI-C-1211
  • CAS Number 1807983-63-6
  • Molecular Formula C31H38N6O2S2
  • Molecular Weight 590.8

Lurasidone Impurity 22

  • CAT Number DCTI-C-1707
  • CAS Number 1807983-61-4
  • Molecular Formula C32H38N6O4S2
  • Molecular Weight 634.81
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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 ActionLurasidone 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.

References
FAQ's

Frequently Asked Questions

Yes, impurities in Lurasidone can affect its bioavailability by altering its pharmacokinetic properties, such as absorption, distribution, metabolism, and excretion. Their control ensures consistent drug performance.

Ongoing research aims to develop more efficient analytical methods and manufacturing processes to minimize impurities in Lurasidone, ensuring it meets the highest quality and safety standards.

Manufacturers implement robust in-process controls and perform regular testing and monitoring of raw materials, intermediates, and final products to ensure impurity levels in Lurasidone are within acceptable limits.

Lurasidone impurities should be stored, at a controlled room temperature, usually between 2-8 °C.

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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