Description

Ubenimex Impurity 2 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the pharmaceutical compound Ubenimex. This material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, quality control laboratories, and manufacturers in the pharmaceutical and biotechnology sectors for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Ubenimex-related impurities during drug substance and drug product analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for purity assessment.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels in accordance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Ubenimex Impurity 2
CAS No.	1654771-89-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ubenimex Related Compound 2; Ubenimex EP Impurity B; Ubenimex USP Impurity; Bestatin Impurity 2; (2S)-2-[[(2S,3R)-3-Amino-2-hydroxy-4-phenylbutanoyl]amino]-4-methylpentanoic acid impurity; N-[(2S,3R)-3-Amino-2-hydroxy-1-oxo-4-phenylbutyl]-L-leucine impurity
EINECS	Contact for details

Quality Control

Every batch of Ubenimex Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. Certificates of Analysis (COA) detailing batch-specific results are provided and align with current industry standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.