Description

R-19-Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a known impurity marker. It is primarily required by analytical laboratories, quality control departments, and research institutions within the pharmaceutical and biotechnology sectors for method development and validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of process-related impurities in Active Pharmaceutical Ingredients (APIs).
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Stability Studies: Used to track the formation of degradation products in drug substances and formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the impurity profile of a drug candidate.
• Research & Development: Facilitates synthetic route optimization and process chemistry studies by identifying and characterizing synthetic intermediates and by-products.

Basic Information

Product Name	R-19-Impurity 4
CAS No.	2096985-18-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	R-19 Impurity 4; R19 Impurity 4; UNII-Contact for details; 2096985-18-9; R-19 Related Compound 4; Impurity 4 of R-19; R-19 Process Impurity 4; R-19 Degradant 4
EINECS	Contact for details

Quality Control

Every batch of R-19-Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques like HPLC, LC-MS, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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