Aripiprazole
General Information
Aripiprazole Impurities and Aripiprazole
Daicel Pharma offers high-quality Aripiprazole impurities, such as 3-Dechloro Aripiprazole, 1-(2,3-dichlorophenyl)-4-nitrosopiperazine, Aripiprazole 4,4′-dimer, Aripiprazole Bromobutoxyquinolinone Analog, Aripiprazole N-oxide Isomer, Aripiprazole Related Compound B, and more. It is vital for evaluating the quality, stability, and biological safety of Aripiprazole. In addition, Daicel Pharma specializes in the custom synthesis of Aripiprazole impurities and ensures their worldwide delivery.
Aripiprazole [CAS: 129722-12-9] is an N-aryl piperazine and an antipsychotic drug. It is effective in treating schizophrenia and mania associated with bipolar I disorder. Aripiprazole treats various other psychotic disorders. It regulates dopamine neurotransmission in patients. Aripiprazole binds to Dopamine receptors (D2 and D3) and serotonin receptors (5-HT1A and 5-HT2A). Further, Aripiprazole is a second-generation antipsychotic medicine. It effectively manages positive, cognitive, and negative symptoms of schizophrenia.
Aripiprazole: Use and Commercial Availability
Aripiprazole is a medicine that treats schizophrenia, manic disorders, and irritability associated with autism. In addition, it treats major depressive disorders and Bipolar I disorder. It helps in the maintenance of chronic schizophrenia in patients. It combines with other drugs for treating psychotic disorders. Aripiprazole is available as an oral and injectable formulation under the brand Abilify.
Aripiprazole Structure and Mechanism of Action
The chemical name of Aripiprazole is 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The chemical formula for Aripiprazole is C23H27Cl2N3O2, and its molecular weight is approximately 448.39 g/mol.
The exact mechanism of action of Aripiprazole is not clearly understood. However, it stimulates and blocks dopamine due to its partial agonist activity on D2 receptors.
Aripiprazole Impurities and Synthesis
During the synthesis of Aripiprazole1, impurities may form that may affect the safety and efficacy of the drug. These impurities form during the synthesis, storage, or degradation of Aripiprazole. As a result, Aripiprazole impurities must be controlled and monitored throughout the drug development process.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Aripiprazole impurities, which includes 3-Dechloro Aripiprazole, 1-(2,3-dichlorophenyl)-4-nitrosopiperazine, Aripiprazole 4,4′-dimer, Aripiprazole Bromobutoxyquinolinone Analog, Aripiprazole N-oxide Isomer, Aripiprazole Related Compound B, and more. A cGMP-compliant analytical facility furnishes the CoA. It provides complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Aripiprazole impurity or degradation product. In addition, Daicel Pharma offers a highly purified, stable deuterium-labeled standard of Aripiprazole D8. Customers can expect a complete characterization report on delivery.
References
FAQ's
References
- Oshiro, Yasuo; Sato, Seiji; Kurahashi, Nobuyuki, Carbostyril derivatives, EP367141B1, Jan 10, 1996, Otsuka Pharmaceutical Co., Ltd., Japan (https://patents.google.com/patent/EP0367141B1/en)
- Kubo, Masanori; Mizooku, Yasuo; Hirao, Yukihiro; Osumi, Takahiko, Development and validation of an LC-MS/MS method for the quantitative determination of aripiprazole and its main metabolite, OPC-14857, in human plasma, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 822, Issue: 1-2, Pages: 294-299, 2005 DOI: (10.1016/j.jchromb.2005.06.023)
Frequently Asked Questions
2.What are some of the known Aripiprazole impurities found in the drug substance?
1-(2,3-dichlorophenyl)-piperazine hydrochloride, (7-(4-chlorobutoxy-3,4-dihydroquinolin-2(1H)-one), (8-(2,3-dichlorophenyl)-8-aza-5-azoniaspiro[4,5]decano bromide, (7-hydroxy3,4-dihydroquinolin-2(1H)-one) are some of the known Aripiprazole impurities found in the drug substance.
3.How are the Aripiprazole impurities formed?
Aripiprazole impurities form from unreacted starting materials, by-products, intermediates, reagents, and degradation.
4.How do we identify degradation impurities in Aripiprazole?
The liquid chromatography-mass spectrometry (LC-MS) method can identify major degradation impurities in Aripiprazole.
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