Description

L-Ornithine L-Aspartate Impurity 6 is a high-purity reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient L-Ornithine L-Aspartate. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of hepatoprotective medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the analytical testing of L-Ornithine L-Aspartate API.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS methods to identify and quantify Impurity 6 during stability studies and release testing.
• Method Development & Validation: Essential for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard to ensure the accuracy and precision of impurity testing in QC laboratories.
• Regulatory Submissions: Provides necessary data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Monitors the formation and level of this specific degradation product under various stress conditions.

Basic Information

Product Name	L-Ornithine L-Aspartate Impurity 6
CAS No.	263860-58-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Ornithine L-Aspartate Related Compound 6; LOLA Impurity 6; Ornithine Aspartate Impurity C; Ornithine Aspartate Impurity 6; (2S)-2,5-Diaminopentanoic acid (2S)-2-aminobutanedioate; L-Ornithine L-Aspartate Degradation Product; L-Ornithine Aspartate Process Impurity
EINECS	Contact for details

Quality Control

Our L-Ornithine L-Aspartate Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous identity confirmation and purity analysis using advanced chromatographic and spectroscopic techniques. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters to support regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.