Description

Crisaborole Impurity 45 is a specified impurity and analytical reference standard used in the quality control of the active pharmaceutical ingredient (API) Crisaborole. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Crisaborole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions to determine product shelf-life.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing necessary impurity characterization data.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during Crisaborole manufacturing.

Basic Information

Product Name	Crisaborole Impurity 45
CAS No.	1785498-37-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Crisaborole Related Compound 45; Crisaborole Impurity F; 5-(4-Cyanophenoxy)-1,3-dihydro-1-hydroxy-2,1-benzoxaborole Impurity; Crisaborole EP Impurity F; Crisaborole USP Impurity; AN-2728 Impurity 45; (1-Hydroxy-1,3-dihydro-2,1-benzoxaborol-5-yl)oxy]benzonitrile Impurity
EINECS	Contact for details

Quality Control

Our Crisaborole Impurity 45 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, 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 guidelines such as ICH.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.