Description

Imiquimod Impurity 6 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Imiquimod. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories involved in the development and production of Imiquimod-based therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Imiquimod API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to improve purification processes for Imiquimod.

Basic Information

Product Name	Imiquimod Impurity 6
CAS No.	99010-99-8
Molecular Formula	C14H16N4
Molecular Weight	240.31 g/mol
Synonyms	1-(2-Methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine Impurity 6; Imiquimod Related Compound 6; 4-Amino-1-iso-butyl-1H-imidazo[4,5-c]quinoline Impurity; Aldara Impurity 6; Zyclara Impurity 6; 1-Isobutyl-1H-imidazo[4,5-c]quinolin-4-amine Impurity; Imiquimod EP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Imiquimod Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, 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 desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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