Description

Cabozantinib Impurity Dx2 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cabozantinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the development and manufacturing of Cabozantinib-based therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control of Cabozantinib API.
• Analytical Method Development: Used to establish and optimize HPLC/UPLC methods for the accurate identification and quantification of impurities in Cabozantinib batches.
• Stability Studies: Employed as a marker to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry R&D: Aids in the identification and control of this specific impurity during the synthesis and purification process development of Cabozantinib.
• Pharmacopoeial Testing: Can be utilized as a working standard for in-house testing against pharmacopoeial monographs where applicable.

Basic Information

Product Name	Cabozantinib Impurity Dx2
CAS No.	1628530-38-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound Dx2; Cabozantinib Impurity 2; Cabozantinib Specified Impurity Dx2; N-[4-(6,7-Dimethoxyquinolin-4-yl)oxyphenyl]-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide Impurity Dx2; Cabozantinib EP Impurity D; Cabozantinib USP Impurity; XL184 Impurity Dx2
EINECS	Contact for details

Quality Control

Every batch of Cabozantinib Impurity Dx2 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator or under an atmosphere of dry nitrogen after opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.