Description

Imiquimod Related Compound D (25 Mg) (1-Propyl-1H-Imidazo[4,5-C]Quinolin-4-Amine) is a high-purity analytical reference standard critical for pharmaceutical research and quality control. This compound matters as a key impurity and metabolite of the active pharmaceutical ingredient Imiquimod, enabling precise method development and validation. It is essential for analytical chemists and quality assurance professionals in pharmaceutical development, contract research organizations (CROs), and regulatory testing laboratories who require reliable standards to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of related substances in Imiquimod drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS/MS methods in compliance with ICH guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products under various stress conditions (heat, light, humidity).
• Pharmacokinetic and Metabolite Studies: Acts as a reference standard for investigating the metabolic pathways and pharmacokinetic profile of Imiquimod in biological matrices.
• Quality Control (QC) and Quality Assurance (QA): Integral for routine batch release testing to ensure drug products meet stringent purity specifications.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Imiquimod Related Compound D (25 Mg) (1-Propyl-1H-Imidazo[4,5-C]Quinolin-4-Amine)
CAS No.	853792-81-1
Molecular Formula	C₁₄H₁₆N₄
Molecular Weight	240.31 g/mol
Synonyms	1-Propyl-1H-imidazo[4,5-c]quinolin-4-amine; Imiquimod Impurity D; Imiquimod Related Substance D; Imiquimod Metabolite D; Aldara Impurity D; 4-Amino-1-propyl-1H-imidazo[4,5-c]quinoline; R 837 Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Imiquimod Related Compound D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for purity, impurities, and chromatographic profile. We support regulatory requirements for reference standards used in pharmaceutical applications.

Storage

Preserve in the original, tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool place. Avoid prolonged exposure to elevated temperatures or humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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