Description

Crisaborole Impurity CAS NO 906673-42-5 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Crisaborole, a topical phosphodiesterase 4 (PDE4) inhibitor. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories. The impurity standard supports method validation, stability studies, and the establishment of impurity profiles as per ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Crisaborole API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with regulatory specifications.
• Stability Studies: Used to track the formation and behavior of this impurity under various stress conditions (e.g., heat, humidity, light) as part of ICH stability-indicating methods.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research & Development: Aids in process chemistry research to understand impurity formation pathways and optimize synthesis routes for Crisaborole.

Basic Information

Product Name	Crisaborole Impurity
CAS No.	906673-42-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-((4-Cyanophenoxy)methyl)-2,1,3-benzoxaborole; Crisaborole Related Compound; Crisaborole Process Impurity; AN-2728 Impurity; PDE4 Inhibitor Impurity; Benzoxaborole Derivative Impurity; 4-(2-Oxo-1,3,2-benzodioxaborol-5-ylmethoxy)benzonitrile (alternative IUPAC); Crisaborole Analog
EINECS	Contact for details

Quality Control

Every batch of Crisaborole Impurity CAS 906673-42-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, analytical methods, and traceability. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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. The material should be kept in a dry environment to prevent moisture uptake. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to 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)	≤ 1.0%

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