Description

Homoarginine Impurity 1 CAS NO 98500-82-4 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in the synthesis of Homoarginine and related peptide-based therapeutics. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of active pharmaceutical ingredients (APIs).
• Analytical Research: Used in HPLC, LC-MS, and GC-MS analysis for the precise identification and quantification of impurities in drug substances and finished products.
• Process Chemistry Monitoring: Employed to track and control the formation of specific impurities during the synthesis and scale-up of Homoarginine and its derivatives.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and control strategies.
• Stability Studies: Used as a marker to assess the degradation pathways and shelf-life stability of pharmaceutical formulations containing related compounds.
• Academic & Contract Research: Supports fundamental research in amino acid chemistry, metabolic studies, and the development of new analytical methodologies.

Basic Information

Product Name	Homoarginine Impurity 1
CAS No.	98500-82-4
Molecular Formula	C7H16N4O2
Molecular Weight	188.23 g/mol
Synonyms	Nδ-Carbamimidoyl-L-ornithine; L-Homoarginine Impurity 1; (S)-2-Amino-5-(carbamimidamido)pentanoic acid; Homoarginine Related Compound A; 2-Amino-5-guanidinopentanoic acid; L-2-Amino-5-guanidinovaleric acid; Guanidino-norvaline; L-α-Amino-δ-guanidinovaleric acid
EINECS	Contact for details

Quality Control

Every batch of Homoarginine Impurity 1 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity, identity confirmation, and impurity profiling. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting compliance with in-house specifications. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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