Description

Imiquimod Impurity 5 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 pharmaceutical products containing the active pharmaceutical ingredient Imiquimod. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in drug development and impurity profiling. The availability of a well-characterized impurity standard is essential for method validation and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Imiquimod drug substance and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and control.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against established specifications.
• Regulatory Compliance & Documentation: Essential for generating impurity profiles and supporting regulatory filings (e.g., for FDA, EMA) to demonstrate product safety.
• Stability Studies: Used to track the formation of this specific impurity over time under various storage conditions as part of drug stability testing programs.
• Research & Development (R&D): Utilized in synthetic chemistry and pharmacology research to study impurity formation pathways, degradation products, and their biological impact.

Basic Information

Product Name	Imiquimod Impurity 5
CAS No.	853793-02-9
Molecular Formula	C14H16N4
Molecular Weight	240.31 g/mol
Synonyms	1-(2-Methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine Impurity 5; Imiquimod Related Compound 5; Aldara Impurity 5; Zyclara Impurity; 4-Amino-1-isobutyl-1H-imidazo[4,5-c]quinoline Impurity; Imiquimod EP Impurity F; Imiquimod Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Imiquimod Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in USP/EP monograph testing.

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% 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.