Description

Rilpivirine Amide 2 Impurity is a designated impurity associated with the active pharmaceutical ingredient Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Rilpivirine-based drug products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Rilpivirine drug substance and finished products.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Rilpivirine formulations.
• Critical for regulatory compliance and filing, supporting Investigational New Drug (IND) and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Supports research and development of Rilpivirine synthesis processes, helping to understand and control impurity formation.
• Employed in pharmacopoeial testing to verify compliance with monographs from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Rilpivirine Amide 2 Impurity
CAS No.	1446439-51-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rilpivirine Related Compound Amide 2; Rilpivirine Amide Impurity 2; Rilpivirine Process Impurity; 4-[[4-[[4-[(E)-2-Cyanoethenyl]-2,6-dimethylphenyl]amino]pyrimidin-2-yl]amino]benzonitrile (IUPAC-based); TMC278 Amide Impurity; Edurant Impurity; RPV Amide 2 Impurity
EINECS	Contact for details

Quality Control

Every batch of our Rilpivirine Amide 2 Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification, to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.