Description

Ketoconazole Impurity 19 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of related substances in Ketoconazole drug substances and finished products. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC/QA labs.
• Impurity Profiling: Essential for identifying and quantifying this specific impurity during the stability testing and release of Ketoconazole API (Active Pharmaceutical Ingredient).
• Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research & Development: Used in studies to understand the degradation pathways, synthesis by-products, and metabolic profiles of Ketoconazole.
• Pharmacopoeial Testing: Aids in compliance testing against standards set by USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other pharmacopoeias.

Basic Information

Product Name	Ketoconazole Impurity 19
CAS No.	1334423-12-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoconazole Related Compound 19; Ketoconazole EP Impurity K; Ketoconazole USP Impurity; 1-Acetyl-4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine (IUPAC); Ketoconazole Process Impurity; Ketoconazole Degradant; Specified Impurity in Ketoconazole
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 19 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and MS to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. We support compliance with cGMP, ISO, and relevant pharmacopoeial standards.

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. For long-term storage, consider desiccants or inert atmosphere.

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)	Total impurities ≤ 5.0%
Any individual unspecified impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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