Description

Ketoconazole Impurity 9 (Ketoconazole Hydroxymethyl Impurity) is a specified impurity and degradation product of the antifungal pharmaceutical agent Ketoconazole. This compound is critical for analytical reference and quality control purposes in pharmaceutical development and manufacturing. It is primarily used by researchers, analytical laboratories, and quality assurance departments within the pharmaceutical industry to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Ketoconazole active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles during stability studies.
• Quality Control (QC) Testing: Used as a system suitability standard in routine QC testing to ensure the specificity and accuracy of impurity assays for Ketoconazole batches.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Helps in identifying and tracking degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of Ketoconazole, enabling process optimization.

Basic Information

Product Name	Ketoconazole Impurity 9 (Ketoconazole Hydroxymethyl Impurity)
CAS No.	170210-42-1
Molecular Formula	C26H28Cl2N4O4
Molecular Weight	531.43 g/mol
Synonyms	Ketoconazole Hydroxymethyl Impurity; 1-[4-(4-{[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-ol; Ketoconazole EP Impurity G; Ketoconazole Related Compound G; (2R-cis)-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
EINECS	Contact for details

Quality Control

Our Ketoconazole Impurity 9 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results, analytical procedures, and traceability. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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