Description

Peramivir Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiviral drug Peramivir. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable supply of this well-characterized impurity is essential for maintaining stringent quality control in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of the antiviral drug Peramivir.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for accurate impurity detection and quantification.
• Stability Studies: Employed in forced degradation and long-term stability studies of Peramivir to identify and monitor potential degradation pathways.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Research & Development: Used in R&D laboratories to study the metabolism, pharmacokinetics, and synthesis pathways of Peramivir and related compounds.
• Pharmacopoeial Testing: Applied as a system suitability and identification standard in testing aligned with pharmacopoeial monographs.

Basic Information

Item	Details
Product Name	Peramivir Impurity 4
CAS No.	229615-12-7
Molecular Formula	C15H28N4O4
Molecular Weight	328.41 g/mol
Synonyms	(1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid; Peramivir Related Compound 4; (1S,2S,3R,4R)-N-(diaminomethylene)-3-[(1S)-1-acetamido-2-ethylbutyl]-4-carbamoyl-2-hydroxycyclopentane-1-carboxamide; BCX 1812 Impurity; RWJ 270201 Impurity; Peramivir EP Impurity D; Peramivir USP Impurity; Peramivir Process Impurity
EINECS	Contact for details

Quality Control

Our Peramivir Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot to support your regulatory and quality assurance needs.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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