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

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!