Brexpiprazole Impurities
General Information
Brexpiprazole Impurities and Brexpiprazole
Daicel Pharma synthesizes Brexpiprazole impurities of exceptional quality, such as 5-hydroxyquinolin-2(1H)-one, Brexpiprazole 3,4-dihydro Impurity, Brexpiprazole 5-1H-Quinolin-2-one, etc. These impurities are crucial to assess the purity, reliability, and safety of Brexpiprazole, an active pharmaceutical ingredient. Besides, Daicel Pharma provides a custom synthesis of Brexpiprazole impurities to meet clients’ demands for delivery worldwide.
Brexpiprazole [CAS: 913611-97-9] is an antipsychotic medication for treating schizophrenia and major depressive disorders. It is similar in structure to Aripiprazole.
Brexpiprazole: Use and Commercial Availability
Brexpiprazole is available under the brand name Rexulti® for treating schizophrenia. It treats major depressive disorder (MDD) and is atypical antipsychotic.
Brexpiprazole Structure and Mechanism of Action 
The chemical name of Brexpiprazole is 7-[4-(4-Benzo[b]thien-4-yl-1-piperazinyl)butoxy]-2(1H)-quinolinone. Its chemical formula is C25H27N3O2S, and its molecular weight is approximately 433.6 g/mol.
The mechanism of action of Brexpiprazole is unknown for treating schizophrenia.
Brexpiprazole Impurities and Synthesis
Brexpiprazole impurities are organic and inorganic impurities. Organic impurities include starting materials, reagents, intermediates, degradation products, and mutagenic and genotoxic impurities. Inorganic impurities include heavy metals and residual solvents. They can form during the synthesis1, storage, or transportation of Brexpiprazole. It is essential to control and monitor the levels of impurities through various methods, such as quality control testing, stability studies, and proper storage and handling of the drug substance and finished product to ensure the safety and efficacy of Brexpiprazole.
Daicel Pharma offers a Certificate of Analysis (CoA) for Brexpiprazole impurity standards, such as 5-hydroxyquinolin-2(1H)-one, Brexpiprazole 3,4-dihydro Impurity, Brexpiprazole 5-1H-Quinolin-2-one, etc., generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity. Furthermore, on request, we can provide additional data like 13C-DEPT and CHN. Daicel Pharma can prepare unknown Brexpiprazole impurities or degradation products and labeled compounds to assess the effectiveness of generic Brexpiprazole. We also offer Brexpiprazole-D8, a deuterium-labeled Brexpiprazole standard useful in bio-analytical research, such as BA/BE studies. A complete characterization report accompanies every delivery.
References
FAQ's
References
- Yamashita, Hiroshi; Matsubara, Jun; Oshima, Kunio; Kuroda, Hideaki; Ito, Nobuaki; Miyamura, Shin; Shimizu, Satoshi; Tanaka, Tatsuyoshi; Oshiro, Yasuo; Shimada, Jun; et al, Piperazine-Substituted Benzothiophenes For Treatment Of Mental Disorders, Otsuka Pharmaceutical Co., Ltd., Japan, EP1869025B1, January 26, 2011
- Bhawar, H. S.; Sanket, Thete; Shinde, G. S., Development and validation of stability indicating RP-HPLC method for estimation of Brexpiprazole from bulk and tablet form, Journal of Drug Delivery and Therapeutics, Volume: 9, Issue: 4, Pages: 141-145, 2019
Frequently Asked Questions
What are the methods for controlling Brexpiprazole impurities?
The methods for controlling Brexpiprazole impurities include optimizing the synthetic process, using high-quality raw materials, employing effective purification methods, and implementing analytical methods to detect and quantify impurities.
How does the presence of impurities affect the shelf life of Brexpiprazole?
The presence of impurities in Brexpiprazole can reduce its shelf life and stability, leading to a shorter expiration date.
How are Brexpiprazole impurities detected?
Impurities in Brexpiprazole are typically detected using analytical techniques such as high-performance liquid chromatography (HPLC) or liquid chromatography-mass spectrometry (LC-MS).
What are the temperature conditions required to store Brexpiprazole impurities?
Brexpiprazole impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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