Description

Ornithine-Aspartate Impurity 4 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound, with CAS number 1174925-92-8, is essential for ensuring the safety and efficacy of the active pharmaceutical ingredient L-Ornithine L-Aspartate by accurately identifying and quantifying this specific process-related impurity. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the production and regulatory compliance of hepatoprotective drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Ornithine Aspartate drug substances and finished products.
• Method Development and Validation: Used in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC testing to monitor and control the levels of Impurity 4 during API synthesis and formulation, ensuring batch-to-batch consistency.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to track impurity formation pathways in drug products.
• Pharmacopoeial Testing: Supports testing to meet the requirements of various pharmacopoeias (e.g., USP, EP, IP) for related substances analysis.

Basic Information

Product Name	Ornithine-Aspartate Impurity 4
CAS No.	1174925-92-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Ornithine L-Aspartate Impurity 4; LOLA Impurity 4; Ornithine Aspartate Related Compound 4; Ornithine Aspartate Imp D; (2S)-2,5-Diaminopentanoic acid (2S)-2-aminobutanedioate impurity 4; Ornithine Aspartate Process Impurity; 1174925-92-8; Ornithine Aspartate Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ornithine-Aspartate Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	98.0% - 102.0% (on anhydrous basis)
Water Content	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5%; Total impurities: ≤ 2.0%

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