Description

Luliconazole Impurity 7 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 (API) Luliconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Luliconazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Luliconazole formulations.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Luliconazole.
• Quality Assurance/Quality Control (QA/QC): Provides a benchmark for in-house quality testing to ensure batch-to-batch consistency and adherence to specified impurity limits.

Basic Information

Product Name	Luliconazole Impurity 7
CAS No.	187164-18-7
Molecular Formula	C14H9Cl2N3S2
Molecular Weight	354.27 g/mol
Synonyms	(±)-N-(4-Chloro-2-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dithiolan-4-yl]methoxy}phenyl)acetamide; Luliconazole Related Compound; Luliconazole EP Impurity; Luliconazole USP Impurity; Luliconazole Process Impurity; Luliconazole Degradant; 1,3-Dithiolane-4-methanol, 2-[(2,4-dichlorophenyl)(1H-imidazol-1-yl)methyl]-4-[[2-(acetylamino)-5-chlorophenoxy]methyl]-, (2R,4S)-rel-
EINECS	Contact for details

Quality Control

Every batch of Luliconazole Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified analytical procedures and acceptance criteria.

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 must be kept under dry, inert conditions to maintain stability and purity. The container should be sealed tightly after each use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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