Description

Crisaborole Impurity 9 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Crisaborole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Crisaborole API batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in quality control laboratories to ensure the accuracy and precision of impurity testing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities as per ICH guidelines.
• Stability Studies: Employed to track the formation and level of this specific impurity in Crisaborole drug products under various storage conditions.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Product Name	Crisaborole Impurity 9 Hcl
CAS No.	1187187-01-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Crisaborole Related Compound 9 Hydrochloride; Crisaborole Impurity 9 Hydrochloride Salt; 5-(4-Cyanophenoxy)-1,3-dihydro-1-hydroxy-2,1-benzoxaborole Impurity 9 HCl; Crisaborole EP Impurity 9 HCl; Crisaborole USP Impurity 9 HCl; AN2728 Impurity 9 Hydrochloride
EINECS	Contact for details

Quality Control

Our Crisaborole Impurity 9 Hcl is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all specified parameters. Production and documentation adhere to relevant standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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