Keywords

• Crizotinib Impurity
• C21H23ClFN5O
• 1801651-84-2

Quick Details

• ProName: Crizotinib Impurity；1801651-84-2
• CasNo: 1801651-84-2
• Appearance: White to off white powder
• Application: experiment research
• DeliveryTime: prompt delivery
• PackAge: Food bags, aluminum foil bags
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Gram/Year
• Purity: 99%+ HPLC
• Storage: cool and dry
• Transportation: DHL,EMS,TNT,UPS,EMS,by air,by sea;
• LimitNum: 10 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

We supply over 20000 types of spot impurity reference materials, with sufficient supply and same day delivery to meet customers' urgent needs for replenishment at any time. The company has its own research and development center and laboratory, and the team members have over ten years of experience in developing drug impurity reference standards. Our website www.molcoo.com covers over 98% of cutting-edge generic drug projects, with complete structural formulas that greatly save customers time in impurity structure analysis and inference. All products undergo strict quality control testing and provide relevant information such as COA, H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetric analysis, IR infrared, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc. These structural confirmation spectra ensure quality and reliability. Our products have a wide range of categories, fast delivery time, good quality, and low prices, which can quickly solve various customer needs such as replenishment and consistency evaluation.

Details

Crizotinib Impurity 21;1801651-84-2

Product Information

• Product Code: C090021

• English Name: Crizotinib Impurity 21

• English Alias: (R)-3-(1-(2-chloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1H-pyrazol-4-yl)pyridin-2-amine

• CAS Number: 1801651-84-2

• Molecular Formula: C21H23ClFN5O

• Molecular Weight: 415.89

Advantages

• High Purity: With a purity of ≥99.0% detected by HPLC, its structure is confirmed by multiple techniques such as NMR and MS, ensuring the accuracy of impurity analysis.

• Strong Stability: Under sealed storage at 2 - 8°C away from light, it has a shelf life of up to 24 months, with high batch-to-batch quality consistency, suitable for long-term quality control.

• Good Regulatory Compliance: Meets the requirements of international drug regulatory agencies (such as FDA, EMA, NMPA) for pharmaceutical impurity reference standards, helping pharmaceutical companies meet regulatory standards.

Applications

• Pharmaceutical Quality Control: Used for the detection of Impurity 21 in crizotinib active pharmaceutical ingredients and formulations. Methods like HPLC and LC - MS are employed to strictly control the impurity content, ensuring that drug quality complies with pharmacopoeia regulations.

• Analytical Method Validation: Serves as a reference standard for developing and validating the detection methods of crizotinib impurities, evaluating the specificity, sensitivity, and precision of the methods to provide reliable means for quality research.

• Process Optimization: During the production of crizotinib, monitor the generation of Impurity 21. Adjust reaction conditions and optimize the synthesis route to reduce impurity content and improve product purity.

• Stability Studies: In drug stability tests (accelerated tests, long-term tests), track the content changes of Impurity 21, analyze its impact on drug stability, and provide data support for determining the drug's shelf life and storage conditions.

Background Description

Crizotinib is a tyrosine kinase inhibitor used in the treatment of cancers such as non-small cell lung cancer, exerting its anti-cancer effect by inhibiting targets like anaplastic lymphoma kinase (ALK). During the synthesis, production, and storage of crizotinib, various impurities can be generated due to factors such as raw material quality, reaction conditions, and degradation. As a specific impurity, Impurity 21 may affect the safety and efficacy of the drug. With the continuous improvement of global drug quality standards, strict control of crizotinib impurities has become a crucial part of ensuring patient medication safety and drug quality, making the research and control of Impurity 21 increasingly important.

Research Status

• Detection Technology: Currently, LC - MS/MS is the main technology for detecting Impurity 21. By optimizing the chromatographic column (such as C18 reversed-phase column with 1.8μm particle size), the mobile phase system (gradient elution of acetonitrile - water with ammonium formate buffer), and mass spectrometry parameters (electrospray ionization source, multiple reaction monitoring mode), highly sensitive detection of impurities can be achieved, with a detection limit as low as 0.01 ng/mL, significantly improving detection accuracy and efficiency compared with traditional HPLC methods.

• Formation Mechanism: Research shows that Impurity 21 may originate from side reactions of key intermediates during crizotinib synthesis, such as incomplete substitution reactions or isomerization reactions. The presence of trace impurities in raw materials, excessively high reaction temperatures, and prolonged reaction times may all promote its generation. Improving reaction conditions and purification processes can effectively inhibit impurity production.

• Safety Evaluation: The toxicological research on Impurity 21 is gradually being carried out. Preliminary in vitro cell experiments show that high concentrations of Impurity 21 have a certain impact on the growth of some cell lines, but the specific toxic mechanism is still unclear. At present, strict limit requirements have been set for it in drug quality standards. In the future, more animal experiments and pre-clinical studies are needed to further explore its toxic characteristics and develop more scientific and reasonable impurity control strategies.

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!