Description

Tavaborole Impurity 16 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 antifungal active pharmaceutical ingredient, Tavaborole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing of drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tavaborole API and drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolism of Tavaborole.

Basic Information

Product Name	Tavaborole Impurity 16
CAS No.	1839665-96-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tavaborole Related Compound 16; Tavaborole Impurity; Tavaborole EP Impurity; Tavaborole USP Impurity; 5-Fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole Impurity; AN2690 Impurity; Kerydin Impurity; (3aS,4S,6R,6aR)-6-(hydroxymethyl)-2,2-dimethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-ol (Potential IUPAC based on common impurity naming)
EINECS	Contact for details

Quality Control

Our Tavaborole Impurity 16 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing batch-specific results and confirming compliance with relevant specifications.

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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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