Description

Imiquimod Related Compound B (25 Mg) (1-Isobutyl-1H-Imidazo[4,5-C]Quinoline 5-Oxide) is a high-purity chemical reference standard essential for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of imiquimod-based drug products through precise analytical testing. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Imiquimod Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate high-performance liquid chromatography (HPLC) and other chromatographic methods.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch release testing to confirm product purity and compliance with stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Imiquimod formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study the properties and behavior of imidazoquinoline derivatives.

Basic Information

Product Name	Imiquimod Related Compound B (25 Mg) (1-Isobutyl-1H-Imidazo[4,5-C]Quinoline 5-Oxide)
CAS No.	99010-63-6
Molecular Formula	C14H15N3O
Molecular Weight	241.29 g/mol
Synonyms	1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-oxide; Imiquimod Impurity B; Imiquimod Related Substance B; Aldara Impurity B; 1-(2-Methylpropyl)-1H-imidazo[4,5-c]quinoline 5-oxide; Imidazo[4,5-c]quinoline, 1-(2-methylpropyl)-, 5-oxide; Imiquimod 5-Oxide Derivative
EINECS	Contact for details

Quality Control

Every batch of Imiquimod Related Compound B is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profiles as relevant for pharmaceutical reference standards.

Storage

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

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 unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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