Description

N6-[(2R,5S)-5-Amino-5-Carboxy-2-Hydroxypentyl]-5-Oxo-L-Lysine is a chemically defined impurity, critical for analytical reference and quality control in advanced pharmaceutical development. This compound serves as a key reference standard for monitoring and controlling the purity of complex active pharmaceutical ingredients (APIs), particularly in peptide and advanced small molecule therapeutics. It is essential for research institutions, analytical laboratories, and manufacturers requiring high-fidelity impurity profiling to meet stringent regulatory standards for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in API quality control.
• Method Development and Validation: Critical for developing and validating analytical procedures to detect, identify, and quantify this specific impurity.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for impurity profiles in drug substances.
• Process Chemistry Research: Used to study the formation and fate of this impurity during API synthesis, aiding in process optimization and impurity minimization.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand drug substance behavior under various conditions.
• Academic and Contract Research: Serves as a precise chemical tool for investigative research in medicinal chemistry and pharmacokinetics.

Basic Information

Product Name	N6-[(2R,5S)-5-Amino-5-Carboxy-2-Hydroxypentyl]-5-Oxo-L-Lysine (Impurity)
CAS No.	75658-82-1
Molecular Formula	C12H23N3O6
Molecular Weight	305.33 g/mol
Synonyms	5-Oxo-L-lysine, N6-[(2R,5S)-5-Amino-5-carboxy-2-hydroxypentyl]-; L-Lysine, N6-[(2R,5S)-5-amino-5-carboxy-2-hydroxypentyl]-5-oxo-; (2S)-2-Amino-6-[[(2R,5S)-5-amino-5-carboxy-2-hydroxypentyl]amino]-6-oxohexanoic acid; 5-Oxo-N-[(2R,5S)-5-amino-5-carboxy-2-hydroxypentyl]-L-lysine; A key impurity of certain advanced therapeutics; Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Every batch of this high-purity impurity standard is produced and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that include data from orthogonal analytical techniques such as HPLC, LC-MS, NMR, and chiral analysis to confirm identity, purity, and strength. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting GMP-compliant workflows. Certificates are available upon request and with each shipment.

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. This product is hygroscopic (moisture-sensitive); ensure the container is sealed in a dry environment after each use to maintain stability and purity. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Specific Optical Rotation	Contact for details
Heavy Metals	< 20 ppm

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