Description

Rilpivirine Desmethyl Impurity is a key pharmaceutical reference standard and impurity used in the research, development, and quality control of the antiretroviral drug Rilpivirine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of HIV-1 medications.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of the desmethyl impurity in Rilpivirine drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch testing to ensure Rilpivirine meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various storage conditions.
• Regulatory Submissions: Required for compiling impurity data in regulatory filings (e.g., for FDA, EMA) to demonstrate comprehensive control of the drug's quality.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Rilpivirine Desmethyl Impurity
CAS No.	500292-48-8
Molecular Formula	C21H18N6
Molecular Weight	354.41 g/mol
Synonyms	4-[[4-[[4-[(E)-2-Cyanoethenyl]-2,6-dimethylphenyl]amino]pyrimidin-2-yl]amino]benzonitrile; Desmethyl Rilpivirine; Rilpivirine N-Desmethyl Impurity; TMC278 Desmethyl Impurity; Rilpivirine Related Compound; Edurant Impurity
EINECS	Contact for details

Quality Control

Our Rilpivirine Desmethyl Impurity is manufactured under strict quality systems suitable for pharmaceutical reference standards. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

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.

Specification

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

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