Description

L-Ornithine L-Aspartate Impurity 7 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient L-Ornithine L-Aspartate, a key agent used in hepatic therapy. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in L-Ornithine L-Aspartate drug substances and finished products.
• Analytical Method Development & Validation (HPLC/GC): Crucial for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure drug substance purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity profiling during the API (Active Pharmaceutical Ingredient) development process.

Basic Information

Product Name	L-Ornithine L-Aspartate Impurity 7
CAS No.	14169-16-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Ornithine L-Aspartate Related Compound; Ornithine Aspartate Impurity 7; L-Ornithine, L-Aspartate salt impurity; 14169-16-5; Ornithine Aspartate EP Impurity; Ornithine Aspartate USP Impurity; Hepa-Merz Impurity; OAK Impurity
EINECS	Contact for details

Quality Control

Every batch of L-Ornithine L-Aspartate Impurity 7 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results from advanced analytical techniques (HPLC, GC-MS, NMR), is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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