Description

Cabozantinib Impurity 1Dyh 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 pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of Cabozantinib, a targeted cancer therapy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cabozantinib Impurity 1Dyh in API batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure API meets stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Regulatory Documentation & Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Cabozantinib and optimizing processes to minimize impurity formation.

Basic Information

Product Name	Cabozantinib Impurity 1Dyh
CAS No.	1621681-63-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 1Dyh; Cabozantinib Impurity D; Cabozantinib Specified Impurity 1Dyh; Cabozantinib Process Impurity; 1Dyh Impurity of Cabozantinib; Cabozantinib (S)-Malate Impurity 1Dyh; Cabozantinib API Impurity 1Dyh
EINECS	Contact for details

Quality Control

Every batch of Cabozantinib Impurity 1Dyh is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity characterization using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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