Description

Crisaborole Impurity 5 CAS NO 2141947-89-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Crisaborole during development and manufacturing. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Crisaborole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing of pharmaceutical batches.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the impurity's behavior and impact.

Basic Information

Product Name	Crisaborole Impurity 5
CAS No.	2141947-89-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Crisaborole Related Compound 5; Crisaborole Impurity; AN-2728 Impurity 5; 4-((1-Hydroxy-1,3-dihydro-2,1-benzoxaborol-5-yl)oxy)benzonitrile Impurity; Benzoxaborole Impurity; PDE-4 Inhibitor Impurity; Crisaborole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Crisaborole Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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