Description

Crisaborole Impurity 16 is a specified impurity of the active pharmaceutical ingredient Crisaborole, a topical phosphodiesterase 4 (PDE4) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Crisaborole drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (forced degradation studies).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes of Crisaborole to minimize impurity formation.

Basic Information

Product Name	Crisaborole Impurity 16
CAS No.	2268785-42-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Crisaborole Related Compound 16; Crisaborole EP Impurity 16; Crisaborole USP Impurity 16; Crisaborole Process Impurity 16; 4-((1-Hydroxy-1,3-dihydro-2,1-benzoxaborol-5-yl)oxy)benzonitrile Impurity; AN-2728 Impurity 16; PDE4 Inhibitor Impurity; Benzoxaborole Derivative Impurity
EINECS	Contact for details

Quality Control

Our Crisaborole Impurity 16 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability is provided with every shipment.

Storage

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

Specification

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

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