Description

Cabozantinib Impurity 46 is a designated impurity reference standard used in the pharmaceutical development 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 analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Cabozantinib.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cabozantinib Impurity 46 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure Cabozantinib batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for minimal impurity generation.

Basic Information

Product Name	Cabozantinib Impurity 46
CAS No.	1247859-37-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 46; Cabozantinib Impurity; Cabozantinib EP Impurity 46; Cabozantinib USP Impurity 46; Cabozantinib Process Impurity; Cabozantinib Degradation Product; XL184 Impurity 46; BMS-907351 Impurity
EINECS	Contact for details

Quality Control

Our Cabozantinib Impurity 46 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), 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 and confirming compliance with relevant specifications. Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep away from incompatible materials.

Specification

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

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