Description

R-20 Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products, specifically in the development and validation of analytical methods. It is primarily utilized by researchers and quality control professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors for impurity identification, method development, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of process-related impurities in active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Used as a critical standard to establish specificity, accuracy, and detection limits for HPLC, UPLC, and LC-MS methods.
• Stability Indicating Method Studies: Employed to monitor the formation of degradation products in drug substances and finished products under various stress conditions.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure drug substance and drug product batches meet stringent purity specifications.
• Regulatory Submissions: Provides necessary data for impurity identification reports required by regulatory bodies like the FDA and EMA.
• Research and Development: Supports synthetic route optimization and process chemistry studies by tracking specific impurity formation.

Basic Information

Product Name	R-20 Impurity 5
CAS No.	2093124-22-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	R-20 Related Compound 5; R20 Impurity 5; R20 Impurity Standard; (S)-2-((S)-2-(4-(2,5-Difluorophenyl)-2,3,9-trioxa-5-azatricyclo[4.3.1.0³,⁷]decan-10-yl)acetamido)-3,3-dimethylbutanoic acid (tentative); UNII-7P8K532A7F; 2093124-22-0; R-20 EP Impurity 5; R-20 USP Impurity 5
EINECS	Contact for details

Quality Control

Every batch of R-20 Impurity 5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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