Exatecan Impurity2 NEW

Exatecan Impurity

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

• Product Information

• Product Code: E068002

• English Name: Exatecan Impurity 2

• English Alias: 2,8-diamino-6-fluoro-5-methyl-3,4-dihydronaphthalen-1(2H)-one

• CAS Number: 143655-59-8

• Molecular Formula: C11H13FN2O

• Molecular Weight: 208.23

• Advantages：As a reference standard for Exatecan Impurity 2, it features a confirmed chemical structure by NMR and MS, with ≥98.5% purity (HPLC), good stability at 2-8℃ in the dark, and high batch consistency. Suitable for impurity analysis of exatecan API and formulations, providing a reliable reference for quality control.

• Applications：

• Impurity Detection: Used to develop HPLC methods for detecting Impurity 2 in exatecan, determining LOD and LOQ, and controlling impurity content to meet ICH Q3A standards.

• Process Optimization: Monitors the formation of Impurity 2 during exatecan synthesis, reducing its content by adjusting reaction conditions (e.g., temperature, catalyst dosage) to improve API purity.

• Stability Studies: Evaluates the trend of Impurity 2 in accelerated stability tests, providing data for storage conditions and shelf life.

• Background Description：Exatecan is a topoisomerase I inhibitor for cancer treatment. Impurity 2 may be generated from residual raw materials or side reactions during synthesis, and its presence may affect drug safety and efficacy. Therefore, strict control of Impurity 2 is a key part of exatecan's quality system.

• Research Status：

• Detection Technology: HPLC-UV with a C18 column (4.6×250mm, 5μm), mobile phase acetonitrile-phosphate buffer (30:70, v/v), detection at 254nm, with LOQ up to 0.05%.

• Formation Mechanism: Impurity 2 may originate from byproducts of intermediate fluorination or amination reactions, and optimizing reaction sequence and purification processes can reduce its formation.

• Safety Evaluation: Toxicological studies show the NOAEL of Impurity 2 in rats is 50mg/kg, and drug standards typically set its limit at ≤0.1%.

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!