Description

Bestatin Impurity 19 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 the pharmaceutical drug substance Bestatin. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling in quality control workflows.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Bestatin active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Used as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance: Essential for routine quality control testing in GMP environments to monitor and control impurity levels during API manufacturing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files and investigational new drug applications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Bestatin to understand degradation pathways.
• Research & Development: Used in chemical and pharmacological research to study the properties, formation, and behavior of this specific impurity.

Basic Information

Product Name	Bestatin Impurity 19
CAS No.	70267-76-4
Molecular Formula	C16H24N2O4
Molecular Weight	308.37 g/mol
Synonyms	Ubenimex Impurity 19; (2S,3R)-3-Amino-2-hydroxy-4-phenylbutanoyl-L-leucine; N-[(2S,3R)-3-Amino-2-hydroxy-1-oxo-4-phenylbutyl]-L-leucine; Bestatin Related Compound 19; Bestatin EP Impurity 19; Bestatin USP Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Bestatin Impurity 19 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, MS, and NMR. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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