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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
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